Transcript-Standards Subcommittee Predictability Roadmap Hearing Day One-December 12, 2018

Department of Health and Human Services National Committee on Vital and Health Statistics

Subcommittee on Standards

Predictability Roadmap Recommendations

December 12, 2018

Omni Shoreham Hotel Washington, D.C.

P R O C E E D I N G S       (9:00 a.m.)

 Agenda Item: Welcome

GOSS: Good morning, everybody. Welcome to the National Committee on Vital and Health Statistics, NCVHS. This is a convening of the Subcommittee on Standards. I would like to call us to order so we can begin our long- awaited subcommittee hearing on the Predictability Roadmap for Transactions and Operating Rules. My name is Alix Goss, and along with Nick Coussoule, we serve as the Co-Chairs of the Subcommittee on Standards.

Nick and I, as well as the other subcommittee members, are very pleased that you are present today for this important discussion, and I would like to just wave to the people at the other end of the table. This is the largest table I think we have ever had in the history of NCVHS hearings, so this is phenomenal. Thank you all for being here today.

First, we have to take care of some official committee business beginning with roll call of the committee members and staff who are present. Then, in a few minutes we will be doing introductions of all the panelists, so I am going to turn it over now to Rebecca.

HINES: Good morning, everyone, and good morning to the committee members, nice to see you all, and members of the public thank you for coming, and our invited guests. We are especially grateful to you for making the time to participate in this hearing and for submitting your written input into the committee’s draft recommendations.

Your input helps ensure that the committee’s work on the Predictability Roadmap is well informed and thoroughly considered, so we are very grateful for your time and effort towards this.

In addition to the input from our invited presenters there will be an opportunity at the end of today and tomorrow for public comment. For those here in the room in the audience there will be a microphone set up. For those who are participating remotely either by phone or Webex, and for those in the room just so you know, there is a Webex with the identical set of slides up so that anyone who is logged in remotely is seeing the same thing and hearing the same thing that you are hearing.

For those participating by Webex or by phone, there are two ways to submit public comments which will be read during the public comment period at the end. They are on the logistics slide.

As noted on the slide, which will be up for the folks on the Webex and here it is in the room, you can either use the Webex dashboard or send an email to ncvhsmail@cdc.gov and we will read the public comments at the end of today and tomorrow. This is separate from the written comments, obviously, that some of you took a great deal of time and care to send.

A few logistical items to note for this meeting. As you all were foretold or forewarned, we don’t have Wi-Fi in this room, but there is Wi-Fi in the main part of the hotel with no password, so, during the breaks if you need to go out that is available.

The mics — This is a new mic system and it’s very simple. There is just one button on the panel that you need to know. It’s the button with the person talking, and you just hit it on and then off. Just remember when you are done talking to turn yourself off and also to speak into the mic. We have a tendency to just talk to a particular person, so just make sure you are in the mic. So, two things — just on/off and speak into the mic.

Lorraine has ensured that we are well sugared-up, so enjoy. There are actually more goodies. Alix brought us the best chocolate known to humankind over on the table.

Let’s begin roll call for just members and staff.

Introduce who you are with and your conflicts.

GOSS: Alix Goss. I am with Imprado, the consulting division of DynaVet Solutions. I am a member of the Full Committee, Co-Chair of the Subcommittee, and I have no conflicts.

COUSSOULE: I am Nick Coussoule with BlueCross BlueShield of Tennessee, member of the Full Committee and co-chair of the Standards Subcommittee, and member of the Privacy, Confidentiality and Security Subcommittee, and I have no conflicts.

LANDEN: Rich Landen, member of the Full Committee, member of the Standards Subcommittee, no conflicts.

KLOSS: Linda Kloss, member of the Full Committee, member of the Standards Subcommittee, co-chair of the Privacy, Confidentiality and Security Subcommittee, and no conflicts.

MAYS: Vickie Mays, University of California, Los Angeles. I am a member of the Pop and Privacy Subcommittees and the Review Committee of this group, and I have no conflicts.

LOVE: Denise Love, National Association of Health Data Organizations. I am a member of the Full Committee, a member of the Standards Subcommittee, and no conflicts.

CORNELIUS: Lee Cornelius from the University of Georgia, member of the Full committee and the Population Health Subcommittee and I have no conflicts.

STEAD: Bill Stead, Vanderbilt University Medical Center, chair of the Full Committee, no conflicts.

STRICKLAND: Debra Strickland, XeoHealth. I am a member of the Full Committee, member of the Standards Subcommittee and the Population Health Subcommittee. No conflicts.

HINES: Are there any members on the phone?

MONSON: Jacki Monson, Sutter Health, member of the Full Committee, member of the Subcommittee on Privacy, Security and Confidentiality, and, Rebecca, it’s really hard to hear on the phone. It’s very faint, and I have the volume all the way up.

HINES: AV technicians, if you can increase the volume on the phone that would be great.

For staff in the room this morning, Marietta? MS. SQUIRE: Marietta Squire.

DOO: Lorraine Doo with CMS, staff for the Standards Subcommittee.

HERRING: Geanelle Herring, CMS, alternate staff to the Standards Subcommittee.

HINES: Thank you. I will turn it back over to Nick.

COUSSOULE: Thanks, Rebecca. I am really happy to see you all here today. Thanks for coming and taking time out to spend a day and a half with us. Part of me thinks it’s going to feel like five minutes and part of me thinks it’s going to feel like five years, but we are very much looking for your input and engagement during the day. It could get a little challenging with this many people in the room so bear with us as we try to herd the cats, and we want to make sure we hear from everybody.

We will go into a little more of the ground rules later, but I am probably going to play the role of bad guy a little bit sometimes if we end up having discussions that take a long time. We may try to punt a little bit of that today so we get through everything and then try to make sure we can cover everything tomorrow with things that WE need to go in a little more depth. So, bear with us as we try to get through that today.

We will do some introductions of the group. Our agenda today is pretty straightforward. Alix and I will give you a brief historical perspective on the Predictability Roadmap so we can level set everybody in the room. Then we are going to spend the bulk of our time really getting all your input on the draft recommendations and surrounding topics to that.

Alix will kick us off with the introductions first.

Agenda Item: Introductions

GOSS: What we would like to do is run the table to make sure that we understand who is with us and you can introduce your name and organization. We are going to ask you to keep it to about 20 seconds if you can possibly do that. It will also help us because I’m not sure, even though I know most of you, that I could read any of your tent cards. As we go through the day, we will be using our tent cards as Rebecca will describe to us later.

ALSCHULER: Liora Alschuler. I am the President and CEO of Lantana Consulting Group. We are a small woman-owned consulting group. We focus on the issues of interoperability. We have done a lot of work in standards development, primarily in the HL-7 arena but not exclusively, and we also, in addition to supporting the development of standards under regulatory banners for CMS, CDC and other agencies, we also work with those who are implementing the standards, so we try to balance both perspectives. And I am very pleased to be here, thanks.

BANKS: Tammy Banks, Vice President Industry Relations. I work with Optum 360, and we basically are a health IT implementation vendor, streamlining processes across all stakeholders — payer, provider, consumer and the intermediaries.

BARLOW: Mike Barlow, Palmetto GBA, Vice President of Operations. I oversee an operation that basically lives with these standards. We are a Medicare contractor and we process about 200 million claims a year.

BEATTY: Gary Beatty. I’m the Chair of the Credit Standards Committee of X12.

BELL: Joe Bell, Chair of the Cooperative Exchange, National Clearinghouse Caucus.

BURCKHARDT: Laurie Burckhardt. I am representing the DSMO, Designated Standards Maintenance Organization. I am currently the Chair for that.

CAMPBELL: I am Janet Campbell. I’m a software developer with Epic. We make health records.

DARST: I’m Laurie Darst, current Chair of the WEDI Board of Directors, and the information I share today will be from the WEDI Executive Committee and also a policy advisory group meeting that we had where we had an equal amount of stakeholders present to provide input on the questions that you provided.

SPECTOR: Nancy Spector, American Medical Association.

TENNANT: Rob Tennant, Medical Group Management Association.

TODD: April Todd, CAQH. I lead the efforts of CAQH Core and the Index.

WALLER: Pat Waller, Cambia Health Solutions. MS. WEIKER: Margaret Weiker, Director of Standards Development at the National Council for Prescription Drug Programs, or NCPDP. We are an ANSI- accredited SDO.

WILBANKS: Martin Wilbanks, Department of Veterans Affairs.

GASH: Deborah Gash, Senior Vice President, Chief Digital Officer for St. Luke’s Health System out of Kansas City.

HEFLIN: Eric Heflin. I’m the CTO of Sequoia Project which works with the Health Exchange and supports the care quality initiatives. I am also the Chief Technical Officer for the State of Texas Health Information Exchange and a board member of IHE USA.

SAWYER: Danny Sawyer, Defense Health Agency. MR. ROOSA: Arthur Roosa with Healthcare Business Management Association, which handles revenue cycle — it’s an association of revenue cycle management companies, and I am also the CEO of SyMed, which is a member company.

MUIR: I am Chris Muir, Division Director of Standards of the Office of the National Coordinator for Health Information Technology.

MIKKILI: I am Minil Mikkili, Kaiser Permanente Health Plan.

LESTINA: Suzanne Lestina. I am the Director of Administrative Simplification Policy at the American Hospital Association and also the Chair of the NUBC.

KOCHER: Gail Kocher, Blue Cross/Blue Shield Association.

KNAPP: Katie Knapp, Veterans Health Administration as a provider.

JAFFE: Chuck Jaffe, HL-7.

HERD: I am Mike Herd with NACHA. NACHA is the not-for-profit association of banks and credit unions for operating rules and standards for the ACH payment system.

NARCISI: I am Jean Narcisi, Director of Dental Informatics with the American Dental Association.

GOODYEAR: Jim Goodyear. I’m a general surgeon and physician, member of the Pennsylvania Medical Association.

GNAGY: Brad Gnagy. I’m here representing HATA, the Healthcare Administrative and Technology Association. They represent about 600,000 providers and vendors.

GINGRICH: Mark Gingrich, CIO, Surescripts, the largest health information network.

SUAREZ: My name is Walter Suarez. I am a member of the Board of Directors of HEMS North America and Executive Director of Health IT, Strategy and Policy for Kaiser Permanente.

GOSS: Thank you. Welcome, everybody. We really appreciate you taking the time out of your busy schedules to not only prepare your remarks and your testimony but to come here today and collaborate with your colleagues to help us in understanding the balancing act that we need to accomplish and advancing recommendations to create more predictability in how we develop, adopt and implement transactions and operating rules under HIPAA.

For the hearing format today, let’s talk about that a little bit. We will be going through each of the proposed recommendations, calls to action and measurement items grouped by the three outcome goals. Each of our subcommittee members will be leading the discussion under each of the outcome goals. We will discuss each recommendation, call to action and measurement individually.

When you wish to say something on any item, we are asking you to raise your tent card. We will track the order and call on you accordingly. We have calculated the time precisely, and, as Nick noted earlier, he’s going to play bad cop if we spend way too much time on a topic, but we also recognize that we want to ensure that we give enough time for all the comments.

Some items we will probably get through fairly quickly. I think there are a couple items that, based upon some of the feedback we have already heard, we are going to spend a little more time on those topics, and we will manage that to the best of our ability.

I am being asked to check in with those on the phone. If you are on the phone and you can hear me, please announce yourself.

BOWMAN: This is Sue Bowman with the American Health Information Management Association.

GOSS: Thank you for joining us since you could not be with us in person today. Nick, I am going to turn it over to you to set the stage.

Agenda Item: Background of the Predictability Roadmap

COUSSOULE: I am going to try to do a little bit of level-setting in regards to the Predictability Roadmap. From a definition perspective, first is that the word predictable has a number of different meanings, but what we’re trying to get to really is that the standards development, adoption and implementation process is not predictable. And by predictable we mean understanding from a timing perspective, a scale or scope perspective, able to do budget planning, implementation schedules, et cetera.

But almost as important is that the predictability itself is the ability to keep pace with the accelerating pace of change in regards to business changes and technology innovations. It is not just predictable from a can I tell what’s going to happen and when perspective, but can I actually accommodate the changes that are happening as fast as they are happening.

I believe most people here would agree that this is kind of a fundamental framing of the challenge we’re trying to address with the draft recommendations.

Secondly is that the Roadmap is an initiative to identify and define the barriers to the updated adoption and implementation of standards and operating rules under the authorities of HIPAA and the Affordable Care Act.

Many of you in the room will have lots of history in this, and one of the things we want to talk about when we get to the predictability is to try to be thinking a little creatively about not only what has happened and why it has happened but what the potentials and opportunities might be. We definitely want to hear about the challenges and issues. We would also love to hear as much if not more about the opportunities that are available to us going forward.

We have been collaborating with stakeholders through really more than 18 months. We started this process a little more than a year and a half ago. Many of you have been involved in several pieces of it along the way. For that, we thank you for the time so far to date and also thank you for your input today. I think what will happen is the recommendations that will come out of these discussions and that work effort will be shared with the Secretary of HHS and covered at the standards and development and organizations operating rule-authoring entities with what expectations might we have for next steps to take place.

The emphasis of the draft recommendations is really it’s a need to improve, and improvement in several different aspects. One is improvements in the federal process. And to try to give a little context around that is a more visible enforcement of existing regulations, more frequent guidance and outreach, and responding to recommendations from NCVHS and to be timely, along with the regulatory activities.

One thing I will say is when we look at the three different categories here it’s sometimes easy to take things in isolation, but oftentimes they need to be considered in a larger context, so, part of what I was talking about earlier. I may push us along to make sure we get through the different topics because, frankly, some of these things stand alone and are pretty straightforward; many of them do not and require other things to happen in conjunction to make them effective. So, when we look at these, we are going to try to make sure we consider not just the individual nature of these but how they might fit together.

And improvements for the SDL processes and improvements to the governance and oversight. I don’t think I need to read the bullets; you all can read that for yourself.

We have heard from a lot of you and others that in order to move forward we must be clear about addressing the barriers and opportunities. Sometimes, we’ll talk a little bit about this as a carrot and stick approach. We want to encourage the industry to do the right things because there’s clear value in there and sometimes we need to force change because, frankly, people’s nature is not to change because they get comfortable. Sometimes, even if you see the end game being very productive and positive it’s very difficult to get there because it’s not without pain or challenge or difficulty.

So we really want to try to hear also today not just about the opportunities but how we might get there and what we might do. One context setting I will say, is oftentimes, we as a committee will discuss how much detail we get into in our recommendations. One of the challenges is do we try to frame up the recommendations at a reasonably high level about what we need to accomplish and how we might go about that, or do we get into a lot of detail about exactly what to do. That is a challenge, and I think when we get through some of the items that we’ll talk about today we will get into that discussion a little bit.

But I think fundamentally we believe that we’re trying to set the context of what we need to do without necessarily all the details of exactly how to get there.

But that’s something that I think we need to challenge each other on over the next couple of days.

We have also heard for many years about the opportunities to improve the governance and stewardship — the last item on the list. So, how are the cost-benefits recognized, who is involved. Alix reminds us on a very regular basis that HIPAA is now 22 years old, and most things — no plan survives first contact with the enemy, the enemy usually being time. So the world changes — unfortunately it doesn’t sit still — which is a good and bad thing, so I think it’s good for us to be able to revisit that at this point in time.

This is our vision statement for this effort.

There are lots of words, and I won’t read through all this. For covered entities and business associates to be able to use up-to-date HIPAA standards consistently, garnering increased value from the standards by avoiding one-off work-arounds, and to reliably know when updated versions will be available and adopted in time to prepare systems, resources and business practices.

It’s a bit of a long vision. There are lots of words in here that we could spend a lot of time trying to parse the individual words — things like consistently and increased value and one-offs. I don’t want to get a lot into that right now. Hopefully, we understand the context and what we’re trying to accomplish and we will get into that a lot today. Hopefully, we will get general agreement that we are on the right path. We may not agree on all the details.

I think we also agree that the administrative standards have significantly improved the efficiency of the system — again, not without pain, but if we look at where we are now versus where we were when this effort first started I don’t think there would be any disagreement that we made lots of good progress and it has made a lot of difference in the industry.

But the question is what now. What do we do now?

What might we change to make it better and easier? By working to improve this process we think we can improve the efficiencies, so, more efficient internal processes for our organizations and certainly interaction between our organizations.

With that, I will turn this over to Alix.

GOSS: Thank you, Nick. The first thing I would like to do is recognize an additional participant who has joined us. Melanie, would you like to enter yourself into the record, so to speak?

COMBS-DYER: I am Melanie Combs-Dyer. I’m the Director of the Provider Compliance Group at CMS. That sits in the Center for Program Integrity. My area of responsibility is in the Medicare fee-for-service program overseeing the contractors that are helping to fight against waste, fraud and abuse. You are probably familiar with the various acronyms that we use for them — MACS, RACS, supplemental medical review contractor in charge of the prior authorization process in the Medicare fee-for- service program. My comments today will be spoken from the perspective of the program integrity part of the Medicare fee-for-service program.

GOSS: Thank you, welcome. Let’s talk a little bit about what we have been up to for the last 18 months, and some of us have actually been working on this since the original HIPAA implementation in the 2003 timeframe. A lot of you have actually been involved in that and some of you have not, and what’s really great is that we have the different perspectives at the table. I really think this is not the end game; this is the beginning of the next phase.

Your input today and the written testimony will be reviewed and we will factor that into our offline wordsmithing exercise to produce a final work product which I imagine will bring about a lot of other activities and further dialogue. So we’re grateful for those of you who have the history and those who have fresh eyes.

We have been undertaking a lot of information- gathering activities, interviews with the standards development organizations which I use collectively to refer to the transaction operating or authoring entities. We received tremendous input at the CIO Forum that really helped hone our thinking into the five theme areas, taking the five theme areas and putting them into a set of outcome goals. The dialogue reinforced our understanding of the need to improve the current processes with consideration of tomorrow’s business models and technology capabilities, which are all right at our doorstep.

After assessing the interplay of change that was necessary based on the themes and the cadence that would be necessary, we identified the three goals that cover the opportunities for improvement related to enforcement and education, stewardship and governance, and improvements in the regulatory process. As you heard from Nick previously, some of them stand alone and some of them are very much woven together.

We are going to spend today on the recommendations and calls to action with a focus on the first two columns. Tomorrow we will work on the third column unless we advance far enough today to start that early, and we will work on identifying priorities and barriers that the group has identified that we need to address.

Some of you may have already heard me talk about the history of this Predictability Roadmap on several Webinars that I have held as well as some of the other committee colleagues. One of the things I wanted to highlight is that the timings in the columns are goals for us to have started if not already have worked towards completion of the activities, but they are very fluid at this point and so we imagine those will be honed.

The format of the hearing today is going to be a little different from what we have done in the past. We are sort of blending the formality of a federal hearing with a roundtable discussion forum. What we’re going to do is have each of the subcommittees lead the review and discussion of the recommendations and calls to action under each of the outcome goal columns. They will provide you with a brief context for the goal and the recommendation, and then we’ll look for you to raise your tent card to let us know that you want to say something.

Having participated in a lot of these forums on standards development work, sometimes one of your colleagues says something that really resonates and you really feel strongly about. So, to be mindful of time but also make sure that we understand the views at the table, if you feel that — let’s just say Gary Beatty says something and you really want to affirm that, you can raise your tent card and say, ditto what Gary said, to give us the opportunity to understand your alignment but also be time-efficient. Rebecca is going to have the task of helping us make sure that we get all those tent cards at the end of the table and that we can call upon you correctly.

We will also have, above and beyond the transcript that will be generated from today’s recording, we have a note-taker to help us keep track of all the comments. Also, to help us all stay focused, we will have the display of the slides, so we know which recommendation, call to action or measurement we’re discussing.

With that frame, let me check and see if there are any questions. With that said, I am going to turn it over to Linda Kloss to lead us through the first set of topics.

KLOSS: Were you going to cover the original questions or not?

GOSS: Thank you. I did miss that step, Linda.

Our original questions that we asked along with the recommendations, calls to action and measurement table, the first one was: How would the recommendations improve the predictability of adopting administrative standards and operating rules? What additional recommendations would you offer, is our second question.

The third one was: What are the desired results of each recommendation? What improvements should we expect to see if and when the recommendations were implemented, and how would we measure those? Are there any potential unintended consequences for the recommendations?

We may have some supplemental questions in our hip pockets to prompt discussion as needed.

Now to you, Linda.

Agenda Item: Discussion of Outcome Goal 1: Outreach, Education and Enforcement – 8 Recommendations and Calls to Action

KLOSS: Good morning, everyone, and thank you so much for coming and for many of you who submitted really fantastic written comments. My airplane ride wasn’t long

enough.

My job is to walk us through the first goal and first set of recommendations and calls for action on each of these. I think the discussion should take the form of either assent, objection or friendly commentary that will make these recommendations stronger. Obviously, we don’t have time to do wordsmithing, but there are some substantive recommendations that came out in your written testimony that would be useful to bring out in the discussion. So that is really our goal and that’s why we’re going to walk through so methodically.

I think this first cluster that we’re going to walk through I call the goal and the recommendation sort of a spotlight goal: Increased compliance and use of the adopted standards and operating rules through greater education, outreach and enforcement. Greater visibility of enforced and increased education will promote more appropriate use of the standards and operating rules.

We’re kind of giving the industry the benefit of the doubt that some of the lagging compliance is due to just confusion because this is a vast and complex area and people change, and it has been 22 years. Many of us assume that this should be all in place but it’s not, and this goal is to say we need to shine a brighter light on this and provide, if you will, some carrots and sticks. So that’s Outcome Goal 1.

Within this there are eight recommendations, calls to action and measurement items under this goal. Three of them pertain to enforcement, three to education, outreach and best practices, and two to participation and engagement in the standards development organizations and their processes — if you will, sort of rallying the industry to recommit to this.

Outcome Goal 1, Recommendation 1 calls on HHS to increase transparency of the complaint-driven enforcement program by publicizing in a de-identified fashion information on a regular basis. HHS should use all appropriate means available to share de-identified information about complaints to help educate the industry about what’s really going on.

I think what comes to mind is what has happened with privacy and security compliance when complaint activities became more transparent and that information kind of hit the headlines. So the idea is that we could benefit by shining a brighter light, and some of the data already exists and it should be publicized.

With that I will stop and see what comments or suggestions there are on additions to this goal or questions about this recommendation. Apologies in advance because I absolutely can’t read the tent cards.

CAMPBELL: A really basic, dumb question. The current complaint process, who is made aware of those complaints today? How does that work?

DOO: The complaints are handled by the Centers for Medicare and Medicaid Services under the Division of National Standards, and there’s a website where some data is available on the number of complaints, and there’s a website where people can submit their complaints.

CAMPBELL: Does that go back to the people who are being complained about?

DOO: Information to the complainants is provided back to them, absolutely. But it’s on the website. What this recommendation is calling for is increasing the transparency of this and making this information more generally available.

TENNANT: I just want to start by thanking the committee and subcommittee and Nick and Alix for holding this hearing. We feel this issue in general really fits in with the administration’s stated goal of reducing administrative burden.

I think, for us, predictability for physician practices also means that you expect that when you send a transaction used in the standard format it will be accepted by the payer. I think the fact that we have had really no enforcement since HIPAA went into effect — and Linda brought up privacy and security — Director Severino from OCR I think stated that they have now reached about $50 million in fines. They also have what’s known in the industry as the wall of shame, which is a public shaming of those who have experienced a breach of more than 500 individuals.

We need to know what’s going on in the industry.

There has to be a consequence to noncompliance. For providers, if we submit a non-compliant claim, it’s denied. That’s the consequence. There is no consequence for other covered entities, so we would encourage not only greater enforcement but also transparency. Not de-identified. This has to be identified. If there has been a corrective action plan issued it should be public, just as it is with privacy and security.

SAWYER: Thank you. Good to hear that interpretation as well in terms of predictability. Our initial answer on this was, in the right context, yes. We didn’t see this as related specifically to predictability. It is something that needs to happen, for sure, that there needs to be compliance, but in the context. And I think it gets back maybe to Nick’s statement of definition of terms.

In terms of predictability, we didn’t see that the compliance piece and education piece actually fit into being more predictable in terms of implementation, though getting the transactions out on a more frequent basis and getting them implemented so that we can have a predictable budget and predictable implementation timeline. So, different definition of terms. And I appreciate hearing what you have to say, Bob, about predictable from a provider perspective. Thanks.

KLOSS: I would just add that I think the overarching goal speaks not just to predictability but to our goal of extending and reaching a level of compliance where we see real administrative savings. I think that’s why this was considered an important out-of-the-gate recommendation.

COUSSOULE: I think that it’s a very good point. We have framed this up as a predictability roadmap, but I think the challenge is a little bit larger than just predictability as far as the adoption, what’s available to adopt and the adoption, but also how do you be effective in the actual adoption and take-up and rule. I understand the point, but I think part of it is that we are trying not to have the box too small as far as what we’re trying to accomplish but make sure that, if it’s predictable as far as the availability of standards, it also needs to be predictable how fast it moves once it gets there. And we believe this is a component of that.

One question I would ask is — and I think it was just brought up — is this a kind of de-identified item or is it an identified item? That’s a different set of challenges as far as kind of a public blame and shame, if you will, to drive differential or education process, to drive hopefully education and continued implementation.

GOSS: Walter, Michael Herd, Arthur, Nancy, Laurie Darst and Joe.

SUAREZ: I was just going to make the same point that was made before about the scope. And in reality, there are some points in some recommendations that are specific to the predictability portion of this effort, but there are many other things that are related to elements that are critical in order to achieve not just predictability but, as you point out, the larger goal of true administrative simplification.

There is no doubt that improved transparency in the complaint and enforcement process is going to be helpful. My concern is that the degree to which and the number of true, real complaints about compliance per se — and I understand and recognize Rob’s point about providers having their transactions rejected by health plans and creating that type of a situation. In many cases that is not necessarily because of lack of compliance by the provider or even the health plan; it’s because some information is missing in the transactions.

So the question is do we know with actual experience and numbers the degree to which there is a compliance issue, because I think we’re making an assumption that there is a compliance problem with respect to the transactions.

As we will talk later at some point, there are other transactions where we don’t see any compliance or we don’t see the use of it — not necessarily compliance but the use of it — because of limited value perhaps or complexity of the transaction itself. But when it comes to the most common transaction — let’s call it that — the claim transaction, do we have a sense, actual numbers if you will, of the degree to which there is a compliance problem with the transaction per se? That would be my point.

And I think emphasizing the earlier point about the role of this particular recommendation in the predictability part is probably somewhat limited, but certainly the role of this recommendation in the larger context of improvement in the administrative simplification process is helpful.

KLOSS: Our larger goal is compliance but also full adoption. I think there is plenty of evidence that a number of the standards are inadequately adopted, as we pointed out in our review report.

HERD: Mike Herd with NACHA. I was basically going to say ditto Rob, but I think predictability can encompass the concept that the counterparts you’re transacting with are compliant with both the standards and the operating rules. I think with respect to the EFT, some of the pain points we are aware of in the industry have to do directly with noncompliance with either the standard itself or the operating rules or maybe other practices that are interpreted by those parties as being acceptable outside of the scope of the regulations or standards.

In our world with payments, we do have an enforcement process. NACHA operates that on behalf of the financial services industry, and I think it’s very important to compliance with the rules — the knowledge that there’s enforcement that could happen if you are not compliant. We do not have a wall of shame. Identities are not exposed publicly, but we do provide our industry with both individual case studies around compliance or enforcement and, also, aggregated statistics on number of cases, the nature and the types of cases and their outcomes.

KLOSS: Would you say that this recommendation is in line with what your experience has been?

HERD: Yes. We think this is a very important recommendation and support it fully.

ROOSA: I wanted to just add my voice to the discussion on predictability and compliance. Without the compliance, predictability doesn’t matter. It doesn’t matter that you know something is coming if, once it comes, you can’t use it and you can’t use it reliably.

I think the issue of whether or not we have statistics on the number of places where it is not compliant — I don’t believe those statistics exist. In our experience, however, most payers and most trading partners who are of some size are compliant. Smaller payers, smaller trading partners, often are not. The problem of working around the smaller guys costs just as much as working around the larger guys.

To Rob’s point of getting a rejection if we do not submit a compliant transaction, one of the other speakers mentioned that, well, there could be something else wrong with that claim. I don’t think he was referring to that, if I can speak for Rob. I think it’s simply if we send a non-compliant transaction to a payer as a billing transaction, that claim does not get paid. If the provider is noncompliant, there’s a penalty. If the payer is noncompliant, there is not. So there needs to be consistent enforcement. As you’re identifying providers and payers who have issues with privacy and you identify them publicly, I don’t see where the issue is in terms of also identifying them by name for trading partners or payers that are noncompliant.

SPECTER: I just want to bring up an aspect of this, going back to just the complaint system itself. We hear consistently that providers are uneasy and apprehensive about filling out complaints because of what they consider to be their dependence on the health plans and potential fear of retaliation. And in some markets, providers have one or two large payers that they’re working with, so, any type of rocking the boat, so to speak, can be very detrimental to that provider.

The other feedback we have had is that the asset system, it does take time and resources for a provider to go in there and have to register, fill out the information, file the complaint formally, do any kind of follow-up.

There is some time and, again, resources that go into that.

Again, it gets back to how invested are they in putting forward that complaint not knowing if the outcome is going to equal the time that they put into it. If they are not seeing any type of consequences on those entities that have been noncompliant, then it’s not, in their opinion, worth their time put into all that.

And going back to Rob’s point, we have not seen any instances where there have been fines or penalties against noncompliant entities. So, until we have buy-in that doing that work of reporting is going to result in consequences that are readily seen for everyone, to get that straight and clear understanding that this is no longer tolerated, it’s going to be hard to convince the provider side to really do that work.

DARST: I’m just going to share some of the comments from a multi-stakeholder meeting that we had, one that the individuals at our WEDI PEG did — support the greater transparency concept. They also felt that once enforcement was established, they should be identified, the entities.

However, we also talked at length about the importance of analyzing the complaints and really kind of getting to the root cause of those complaints. It’s an opportunity to try to have that understanding and do education with an end goal of us really having better administrative simplification. So it was a supported recommendation.

BELL: One of our points was that the HHS stated goal of remediation, not punishment, should remain a foundational principle to drive and align standards compliance within the healthcare system. Although we have talked about fines, I think it would be very difficult to find a state Medicaid organization. And as far as what is the true goal, the true goal needs to be to get people in alignment with the standards, not doling out penalties.

Because I can tell you that there are some organizations that have basically looked and said you can’t charge us enough to be compliant because it will cost us more to try to become that.

That leads into the reason, the stated goal of being able to understand why are organizations not compliant. Is there an adoptability issue? Is there a financial issue? What is that? If we can basically focus on correcting the problem, getting people in alignment and understanding why those people weren’t in alignment to begin with, I think we can go a long way to getting this predictability done.

KLOSS: I think we’re getting into some points that are going to come out in recommendations to come, and I am ready to move on. But I think we have one more comment.

GASH: I just want to echo what Rob has said and just add the reason the privacy and security wall of shame is effective is because it’s identifiable. But there’s a threshold for reporting, and perhaps you could mirror that in saying the volume of complaints or the significance of the complaints would drive the reporting. That would be my only addition.

SAWYER: The thought is, if there is a compliance rule — different chunk. So maybe we chunk this differently. If we put too much into one piece of legislation I think it may be even harder to get through. But if we address the compliance piece individually with a compliance rule that’s going to have some teeth to it, that’s great, and then the predictability piece, the other things we’re talking about, as a different part of legislation, the may have more of a chance to get through quickly if we don’t try to do too much in one big chunk.

BANKS: I just have a question. I kind of feel like I’m in a time warp and I’m in 2012 and we talked about this last time. Same comments. Many of us were still here, unfortunately.

But the question is on 1 and 2. I know you are not on 2. All it is is asking HHS to enforce the provisions that we strengthened in ACA and we strengthened from HIPAA.

KLOSS: Let’s move to Recommendation 2.

Recommendation 2 is: HHS should comply with the statutory requirements for handling complaints. To date, CMS, while they have authority, has not levied any civil monetary penalties against any organization for noncompliance.

Perhaps regular predictable information about the enforcement program could not only alter the perception of the complaint program but also, more importantly, improve consistent use of standards and operating rules. So, carrot and stick again. More information reminder. Yes, I’ve got to get on with this; I had better do this to be a good citizen and for people to want to do business with me.

And on the stick side, at some point, there needs to be some penalties with teeth. And I think the comment was made let’s look at this perhaps in tiers and look at what level would rise to a point of identifiable penalties.

Any additional comments on this? Rob?

TENNANT: Let me put just a slightly different spin on our discussion. There are two issues. There is one of noncompliance with regulations in terms of the law, but there is also the spirit of the law. The idea behind HIPAA and 1104 of the ACA was to drive out administrative costs in healthcare.

What we’re seeing at the ground level of healthcare are a number of bad actors who are actually imposing barriers on the use of the transactions. Not so much an issue of compliance, but, for example, they’re charging fees for the transactions. In fact, I’ve got a member who sent me some information about their payments being sent via EFT but there was a fee attached to it. So that’s a discouragement for using the standard transactions.

I think when we’re looking at this we need to be looking at other barriers besides strict compliance with the transactions. We all know from the Index that payers are driving providers toward use of web ports. It’s much easier for the plans but much more challenging for providers. So there has to be a way to address this growing concern which is not encouraging providers to use the standard transactions. Thanks.

KLOSS: Are there other comments on Recommendation 2 calling on HHS to use the regulatory levers that they have?

NARCISI: I think the one thing that didn’t come out in the discussion of the previous recommendation or for this one is that, of course, we support everybody being compliant, but for those that are noncompliant I believe HHS, CMS or whoever is going to do this needs to analyze this data and then come up with some industry guidance to everybody. Maybe that will help with eliminating some of the complaints.

KLOSS: That is a wonderful segue to Recommendation 7, which is what we were teeing up next to look at. Again, a reminder that these recommendations that we’re looking at are in the first time block, the 2019 to 2020. We know that even if the recommendation goes forward to HHS it can’t necessarily be fully implemented in this timeframe, but we could and would expect or hope to see substantial change.

This recommendation, as Jean pointed out, calls on HHS to regularly publish and make available guidance regarding the appropriate and correct use of the standards and operating rules. The presumption most certainly is that it will be informed by complaints and information from the industry on what’s working and what is not working, so, that information we would call upon HHS to make easily accessible for stakeholder groups.

And in this recommendation NCVHS intends that HHS would provide guidance on the policies related to the use of standards and operating rules and would point to appropriate industry resources for technical guidance, for example, the standards organizations.

Any comments, suggestions? Margaret is in the queue and then Walter and then Rob.

WEIKER: Linda, in regard to what you said at the end, that was something NCPDP thought of as well. We agree HHS should regularly publish guidance but that it be done in conjunction with the appropriate SDO if it’s SDO- related type of questions or guidance.

Also, in the guidance they should point to the mechanisms that the SDOs, or at least NCPDP, have in regard to having entities covered and non-covered entities ask a question about the appropriate use of the standard. We have a mechanism at NCPDP. We publish a recommendation guidance separated out sometimes by Medicare Part D because we get a lot of questions around Medicare Part D — so we are in agreement — but if it’s technical in nature, if it’s about the standard, that it be done in conjunction with the SDO.

SAUREZ: Margaret just covered exactly what I was going to say. I totally agree that more guidance from the regulators is good, but I’m concerned about the degree to which the regulators should get into technical specifications of the standard versus policy guidance. I think there’s a big difference in that. I totally support the concept that, when it comes to technical guidance, that guidance should come from the SDO that supports the standard rather than from the regulator.

KLOSS: Would it be both of your suggestions that the recommendation be slightly modified to incorporate that spirit, not just in the explanation?

SUAREZ: Yes, I would support that, too.

TENNANT: I would support that as well. If there’s a technical issue it should be the SDO.

But let’s talk policy, and let me give you an example that I think illustrates the importance of the recommendation.

WEDI, as a multi-stakeholder group, developed a workgroup co-chaired by a provider and a health plan to develop principles or guidance around the issue of electronic payments. They met, they had a large workgroup, and they came up with a consensus set of principles. In fact, CMS sat on that group. That was translated into guidance that was published on the CMS website giving policy guidance to the industry regarding e-payments — all fantastic news.

Now comes the bad part. Summarily, they were withdrawn from the website with no reason. There’s an example of where it allows, again, bad actors in the industry to take advantage because there’s no direction provided by the government. So we would encourage a reposting of that guidance on this particular issue, but looking at other transactions to see if there are policy levers that could be pulled to, again, encourage greater use of the transactions.

MIKKILI: Ditto what Walter and Margaret said. There should be a regular publishing of that, which really helps the industry, but where does it lie? Is it on the SDOs or a collaboration of SDOs, or is it on a case-by-case basis?

HERD: Of course, we support this recommendation. It’s kind of like apple pie. But I would agree with those who said it should also incorporate guidance that is official from SDOs or from WEDI. I was going to mention the WEDI EFT white paper on best practices for EFT. It’s an excellent white paper. I don’t see any reason why that shouldn’t be official guidance from HHS about use of the EFT.

I just want to reiterate Rob’s comment about the guidance that was posted and withdrawn and how disappointing that was for those of us who work in that space, and to put all that effort and to actually have guidance be issued and then withdrawn.

BEATTY: I would also like to echo the comments. But in addition to the SDOs — and the SDOs are closer to the context and what’s in the standards from both the business and technical perspectives. But I would also like to add that we also need the operating rule entities involved because they work cooperatively with each other, and to do one without the other would not do justice to the industry. So it’s not just the SDOs; it’s also working cooperatively with the OREs as well.

GINGRICH: It’s another ditto to Walter and Margaret.

GOSS: I appreciate that. It’s good to know the strength of the feedback.

SAWYER: This is primarily a WEDI function. I appreciate, though, hearing especially if WEDI had done the work and then it got published, but it seems like this particular recommendation is something that WEDI is already supposed to be doing.

JAFFE: From an HL-7 perspective, we appreciate the direction given in policy from the various HHS agencies and from other government agencies for whom we provide not only the technical but also the administrative support.

From our viewpoint, however, the policy, the outcomes should be defined rather than the technical pathway to achieve it. The support that ONC has given us over the past years has really corroborated this viewpoint. They presented some objectives and allowed us to develop the standards, specifications and implementation guides necessary to achieve it. I recommend that we continue that process.

GOSS: April is next.

TODD: I just want to add from the CAQH Core perspective as an operating rule entity, we would support the comments that Margaret made. I would also add that, in addition to HHS providing awareness around the availability of operating rules and standards and where you can provide guidance, but also areas to find technical assistance. For example, Core has a certification program where entities can test and make sure that they are using the operating rules correctly. It would be helpful for HHS to make available where there is technical assistance for help as well.

HEFLIN: I think the guidance is necessary but is not sufficient. I think history really has shown, if you look at positive examples where the entire country was asked to adopt changes successfully and in a timely manner, one of the keys for that is also publication of a reference implementation. I think a prior commenter stated that part of the problem is not in the bigger players in industry but the medium-sized and smaller. And someone else made a comment a few moments ago that the cost of any potentially viable penalty is actually less than their expense of implementing.

So I think it really underscores the point that reference implementations are truly a necessary portion of any large-scale, fairly timely adoption of any technology, whether it’s financial services or healthcare of other areas.

Another item that I think is also useful is a free validation system also published at the same time. Ideally, how I see this play out is the guidance is published at a high level, not detailed though because the SDO will provide the detailed guidance, and the detailed specifications developed by competent and current industry experts in that domain, and then a parallel that the federal funding be provided to SDOs to bring together members of the broad community to help create the technical specifications and a reference implementation, and, in parallel, a current best practice of software developments is employed, which is you develop your test program at the same time you develop your reference implementation.

So, basically, you are done with your reference implementation once all tests pass, and essentially that can also have the added benefit of being a specification for the industry and for the reference implementation as well.

The challenge we have where the federal government has been overly prescriptive in terms of guidance and regulations is that it actually has the inverse effect of stifling innovation because, by being overly prescriptive in regulations or in legislation, it actually can essentially create a barrier for innovation because the industry cannot move past something that is potentially an obsolete reference in regulation.

ALSCHULER: A bit of a ditto to both Chuck and Eric. I would like to say that, in a sense, looking ahead to the other recommendations, the guidance issue is really a product of how the standards are developed and the policy is developed from the get-go, so, looking at current regulations. We can’t go back and sort of redo how we did those. But looking ahead to how the industry moves together in the future, it’s really critical to understand that guidance that is very difficult or expensive to comply with will never be complied with, and so no guidance is really going to get at the root of the problem. Continual tests and development of reference implementations from the beginning of the process is really where this issue of outreach needs to begin.

And just amplifying and broadening a little bit what Chuck said, where collaboration between policy and standards development is as close as it can be in an ideal world, then the guidance is much simplified and can come from a unified source. We are often asked to help someone look at what’s coming from policy, what’s coming from the standards and mesh them or simplify or unify them because they are disparate. And after a standard is published, then regulation cherry-picks a little bit, takes from here and there and adds constraints and changes it so that the implementer then has to look at two places.

So, just broadening that concept that it’s really a question of collaboration which will simplify how guidance can be provided. Thank you.

COUSSOULE: I think there’s an interesting question that has been raised in regards to the level of detail that’s inherent in policy versus being done kind of from an implementation perspective or guidance, and that topic will come up several times over the next couple of days and we really would like to get good feedback from the people in the room on that.

From my perspective, what’s the hardest thing to change as things move forward? Policy. So, the more detailed and more prescriptive you get as far as policy the less flexibility you may have. At the same time, how do you enforce things that aren’t in policy? So I think that juxtaposition is a really interesting one and one that we will hopefully explore more over the next couple of days.

1. ROOSA: First, I just want to ditto what Chuck and Margaret have said. I also want to say that I think there’s a mistake that I’m kind of hearing that, if we have a guidance, somehow there’s an incentive to follow that guidance. I think something to be considered is that the incentives are misaligned in the healthcare industry.

NACHA, for instance, with the financial services industry there’s a financial incentive for the whole banking industry to follow the same standards. It is not the same way with healthcare, and so there’s a need for not just guidance but the understanding of bodies that are enforcing that guidance to know that there is a role to do that and there’s a need for that enforcement to take place, just not for the guidance to occur.

A quick story that I tell from time to time is that earlier this year I was in Bhutan, and there is a single ATM in Bhutan, in the entire country, one ATM. However, I could go to that ATM and I could withdraw from a

U.S. bank. And the only way that happens is adherence to standards, and that happens because the incentives are aligned with those standards. So there is a need I think for us as an industry to understand that we need to develop something that there are incentives within the industry to actually be in compliance with the standards.

DARST: I just wanted to share the WEDI multi- stakeholder input that’s really dittoing what was said before about encouraging more education and having to go to the SDOs for the technical expertise.

The one thing that has been said a couple of times and Rob brought it up is WEDI’s focus many times is really on the implementation, in coming up with best practices, identifying issues. And we would certainly offer our expertise if there’s assistance that we can help CMS with any kind of input. Again, with the technical expertise of the SDOs along with WEDI, we would certainly be there to help with that.

GNAGY: I want to ditto Liora. A lot of this is based upon — we’re discussing integrating or getting information from the communities, and we’re doing this right now, and we’re gathering data, getting information. A lot of these things are based on the information that we can gather and what information we do gather, so a lot of this can be affected directly by how we’re going to implement and some of the processes of implementing these standards, and how we’re getting the data and assimilating that data into our predictability, because that’s directly related to what you can predict, is how much you know and how much you are able to gather.

So a lot of this can be potentially affected by looking at the implementation of this differently and allowing for us to get more information. This is more, yes, I agree. There are other ways that we can also speed these processes up, gather more information and get that from the community faster through implementation procedures.

COMBS-DYER: Melanie Combs-Dyer, CMS, Medicare fee-for-service program integrity. I would like to ditto the comments of Eric Heflin with respect to how we need to be careful in this discussion today not to stifle innovation. I think that’s a really important comment, thank you.

BANKS: I just have two comments. One is I don’t know if we want to reword Recommendation 7, because I’m starting to hear two different things which are distinct. One is the guidance that is actually enforceable, and then there’s the guidance that provides recommendations, and separating those two would be helpful.

I also want to add on to Dr. Jaffe because if I heard you correctly — and this is a point I wanted to raise later but maybe this is the right place to have it — is the prioritization of the industry. We at the White House clearly indicate that pricing transparency, accessibility of medical records, prior auth and other administrative burdens are the key focus areas for us in this industry, and we need to have that on an annual basis. What is our common collective focus is to put resources — again, not just stifle innovation, but to help us all build and move forward collectively to address these big issues and streamline the workflows. I don’t know if that’s another recommendation or if it’s HHS.

And the other add-on that I was going to bring up later is we have non-mandated standard transactions, and I have to go to X12 just because I’m more familiar with them than the other standards even though it’s across all standard organizations, and it would be helpful — and I know we talked about the ONC ISA publishing the administrative standards and I appreciate you guys putting those in. Thank you for that.

But those organizations like CMS and other large volume exchange of standard transactions that aren’t mandated, if they could be identified so we know where is the shift in some of these non-mandated transactions.

Because, remember, volume brings ROI, and if a large part of the market is moving toward using a non-mandated standard, more of the industry will move there as well because we have connection partners.

So I am unsure if that would be HHS or ONC, but I really didn’t look at it as a regulatory; I looked at it more as an awareness education piece to move the industry voluntarily to gain more momentum. Thank you.

KLOSS: I think a number of themes have come out in this discussion that we will certainly be revisiting as we continue to move through the recommendations. Tammy, I take your comment about clarifying what we mean as guidance and differentiating types of guidance as highly relevant to this recommendation, but we have some other policy alignment issues that will come out in the course of discussion.

Now this is Outcome Goal 1 in this near-term timeframe, and it’s a measurement goal and so we would appreciate your input on this. We’re recommending that HHS should publicly and regularly disseminate results of its enforcement program to promote transparency opportunities for education and benchmarking.

With respect to this measurement goal, our question to the group is whether it serves the purpose of measurement to evaluate the progress. Is this sufficient, or what would you suggest be additional informative and educational kinds of measurement that can align with these education and outreach goals? What else, what other data would be helpful to the industry?

BANKS: You can measure how many compliance disputes were handled, how many progress reports were identified. That type of measurement makes sense. And then we could see an increase. Because if we believe enforcement is not occurring — I’m not saying it’s not, but if we have a baseline then we know if it’s increasing or decreasing and what is the market doing in regards to the good efforts of CMS to address.

And then the second — I think the recommendation we were talking about was publication of clarification or recommendations and, also, clarification of enforceable information. So again, those could be quantified. It can either be quantified how many were sent out or quantified how many requests to have that clarification. Obviously, if you have more requests, we’ve got an issue with the way things were written and need to revisit it here in this forum to see what should be.

So, if we can make it actionable and more objective, I think it would be helpful to the industry.

ROOSA: Just quickly, simply disseminating the results of enforcement actions would provide data that people could go to and actually draw significant benchmarking from. I certainly support the other issues that the previous speaker just mentioned, but I think maybe the implication at the beginning of this section was that you can actually draw a lot of information just from knowing what the enforcement actions were.

TENNANT: Maybe the word that’s missing here is the word audit. It may be part of enforcement, but it’s sort of a separate issue. I’m so happy that Melanie is here because she can attest to the fact that CMS loves to audit providers —

(Laughter)

—  although we would be absolutely pleased if she adopted the approach of only auditing those who volunteered to be audited — and that’s exactly what we have for HIPAA enforcement. They are only auditing those that come forward. And while that might be interesting, I’m not sure it’s really going to get us where we need to go.

I would encourage that there be a broader auditing program because that will help, as Art said, with the benchmarking, because we need to know what’s going on out there in the industry, and by self-selecting a handful of folks that are probably already compliant, that’s not really going to push the ball down the field.

So, I would encourage a broad-scale auditing program. You can de-identify that, as does OCR when they do their audits for privacy and security. You can break it down by stakeholder group. It can be a very effective approach and would be helpful, quite frankly, to WEDI to know where the problem areas are so WEDI and other groups could target some education.

KOCHER: I think this whole concept of measurement and transparency is excellent, but we have to make sure that the goal of that is really to educate and improve the system. The goal can’t be to point fingers at people and shame people like we’re five-year olds in a sandbox. We have to have the right goal.

And then we have to be transparent across the whole spectrum. It can’t be transparent for one stakeholder group and not transparent for the other. Otherwise, we are never going to get to the point where we can all come to the table together, identify the best practices like we’ve talked about WEDI is able to do, and work towards making it more administratively simple for everyone across the systems.

BELL: I echo that. I think the statistics will be a good way to show where the state of the industry is. Unfortunately, without audits and collecting that information and things — we can’t send out a questionnaire saying, hey, who’s not compliant. I don’t think a lot of people are going to answer that question.

But I think it’s important to understand where the industry is and why the industry is that way because I’m concerned about valid push-back from the industry saying the cost of compliance costs us X amount of money and somebody has to pay for that, so, are we merely shifting cost from stakeholder to stakeholder or are we truly reducing cost of the process and that, by having the measurements, we should be able to substantiate that we’re achieving our goal of reducing cost rather than just shifting cost.

HERD: Clearly, we would support the goal on the assumption that there is enforcement, and then information disseminated about what it is and what the results are I think is useful for the industry to learn from and to educate and to train.

Just by way of analogy to our industry and our enforcement, this reads very similar to what our purpose is with enforcement of the NACHA rules. Its fundamental purpose is — I have heard the word remediation. We would call it compliance first, and fining is like the last resort. If we get to the point where it’s a fine, then there has been a failure, but the purpose is compliance first and foremost.

The other comment I would make is that, also by way of a comparison and you all can consider it for what it’s worth, we do have an annual audit requirement for compliance with the rules. Any financial institution in the payment system or any third party that supports a financial institution in the payment system does have an annual rules-compliant audit requirement.

GNAGY: Two things. In this here, does this also detail what the outcome was, what the fix was to it? And if there was a fix, how it was accomplished? Because during this education it would be nice to know these are all the problems that are out there, and this is how they were resolved.

And to Joe’s point, as we go through this, the more I look at it the more I see that the consequence might mean the smaller guys just disappear in this industry. You know, if we started, like you say, shifting costs, if the smaller guy looks at it and says well, I may as well just get in the financial industry because I won’t be fined X amount of dollars if I get 500 records stolen; I could get six million records stolen and not have anything happen to me if I’m in this other industry.

HEFLIN: Before I actually did a little research to test out the theory whether things like walls of shame actually work or not, I actually had the hypothesis that they don’t work. However, I did find there’s actually quite a bit of evidence that in fact they do work. For example, there are some academic publications that investigated this rigorously and said that shaming or the equivalent to professionally calling organizations out that are not compliant fills a void where law does not address issues, at least at a certain point in time.

Another bit of evidence is the cybersecurity work, an area of my personal focus, that there is now a fairly standard practice that organizations are given 90 days to remediate a security vulnerability; otherwise, they are publicly disclosed. And for those that go through the pain of seeing their vulnerability publicly exposed because they don’t fix it in 90 days, it’s extremely painful for those organizations.

In the Health Exchange, with which I’m associated, we actually have 100 percent compliance. Every single member of the Health Exchange, which is the operational network for healthcare data exchange, is compliant. The reason we know that is we test for it regularly. We make sure their cybersecurity profile is reasonable; we make sure the content quality is interoperable and of a certain degree of quality. We make sure transport is also conformant with our standards and specifications. So there’s a real benefit I think to identifying by name those organizations who are not conformant and, also, by testing for conformance.

SAWYER: I’ll be a bit of a broken record. Is this discussion on Goal 1 really having to do with compliance enforcement, and is this to get input toward a compliance enforcement rule? Or is this going to actually then be part of a predictability roadmap type of piece of legislation?

Again, it seems like we have been looking for the enforcement rule for a while and so maybe that’s where we’re going with this, and that would be good. But if this gets rolled into a predictability roadmap, I’m a little concerned that we’re putting too many things together into one package.

KLOSS: I think, to quote someone else earlier who said that without compliance predictability is not meaningful, I think it’s in that spirit that this cluster comes together. Chris?

MUIR: I just have a couple of comments. One, I think it’s kind of implied but I think it is helpful to highlight that going through this process that roadblocks for people to become compliant be highlighted, and the disincentives in the systems as outcomes. I think that would be extremely helpful

KLOSS: I think that brings us to the end of this cluster. Without really stating it, I think the co- chairs have clustered together early recommendations that are an easier lift than what we’re getting to as we progress. But you have done a wonderful job in providing us with some real meaty feedback on these, and we are very grateful.

GOSS: We are doing fabulous on timing despite the robust level of feedback. I love that you guys have got this down pat now. What we want to do is try to see if we can eke a few more out. Denise, if you want to take us to the next level and we will try to break a little bit earlier than 11:00 o’clock, which is when we were slated to break, but then we can return and have a full hour before we break for lunch.

So we’re going to jump to the next one. Over to you, Denise.

LOVE: I am Denise Love, and I’m going to move to the calls to action under Outcome Goal 1. In these calls to action the subcommittee has described opportunities for the industry to participate in process improvements. I think some of what I will go through is sort of linked to what we were just talking about, and in some of these recommendations we have included HHS as a party to the activity. As I read through these you will see that much of the work is being ascribed to stakeholders to carry out some of these recommendations or calls to action.

Call to Action A: Health plans and vendors should identify and incorporate best practices for mitigating barriers to the effective use of transactions and determine which issues are most critical and prioritize use cases.

The assumption is that health plans, clearinghouses and vendors are the primary drivers of the transaction usage and, therefore, through their collaboration, have many of the insights that can advance the administrative simplification. The note that we have heard is that providers are the ones bearing the burden when the standards are used in a non-standard way for business purposes.

This call to action really is to highlight what we heard as best practices or understanding barriers, and so we will take a minute if anyone has any thoughts about how this could be implemented and what are some of the challenges to facilitate these insights and sharing.

NARCISI: We believe that WEDI should be the entity that’s the convener of all these stakeholders, the reason being that that is what WEDI does already. But I think if it was more recognized by your recommendations that would be helpful.

LOVE: As I read through these slides, this slide and the next slide are rather linked, so just recognizing that.

KOCHER: We fully support the concept of collaboration, but we do think the providers need to have a stake and a seat at that table as well. Even though, in some instances, vendors are doing work on their behalf, it is still the provider who’s a covered entity. They have accountability and responsibility under the regulation, and it’s their business. So, as a health plan, we want to make sure that they are at the table.

If the next slide is Call to Action B, I would say ditto to what Jean said. We think that WEDI plays an important role in the ability to pull all the stakeholders together to have those conversations, to identify best practices and help to mitigate barriers as we move forward, and try to have better implementation, both the business and technical aspects of that.

WEIKER: NCPDP consistently promotes the effective use of the NCPDP transactions through our SNIP committee, our frequently-asked questions and our best practice guides. And we encourage health plans, vendors and providers to consult with the appropriate SDO or operating rule-authoring entity in regard to any barriers or issues regarding the standards.

DARST: Speaking on behalf of WEDI, I can’t believe I’m going to ditto that we are ready and willing to convene this type of discussion. We would very much welcome this. It’s something we already do and I think we do very well.

GASH: I just want to strongly echo Gail’s comments that you need to include the providers in this workgroup because we are the ones who feel the problem and know where the barriers are and might have some great suggestions for development of new standards and transaction types that would help drive down the administrative burden of processing these transactions.

LESTINA: I’m dittoing Gail and Deb on that strongly as well. The providers need to be involved. You can’t out-source compliance. They need to be a part of this conversation.

TODD: I just want to add my ditto to this discourse, too, and actually provide a little background. As part of doing the CAQH Index, we interview providers related to adoption of the standards, and their perspective is extremely valuable in understanding why transactions are being done manually. I don’t think that perspective can be ignored in this.

GNAGY: Obviously, collaboration here is key, and how we’re going to do that — WEDI was named as a potential. What are the other elements that offer us the opportunity to get the community involved? How are we going to do that? In a large scale right now, we have this many people in the room, but within the structure that WEDI currently has, what does that look like? Is that across the entire community?

We were talking about providers being involved. What about the IT professionals of the providers and the vendors that support the providers, the people who are actually in there doing the hard work and innovating the work-arounds, the people that I employ, personally?

I think there are a lot of opportunities, a significant number of opportunities for us to have community involvement at an incredibly high level, and so I definitely think that we need to pursue these opportunities and discuss them with gusto.

GOSS: I actually want to chime in here for a second. The strong echoing of getting the providers at the table — I am all for it. One of the reasons they weren’t included in the original scoping of this is because we always hear about the provider burden. We also hear that providers — there’s the expense beyond the burden of the providers who want to focus in the clinical areas. The participating in the standards development and the policy work and the operating rule-authoring is not where they want to play, nor do they want to play to pay.

So I would be very interested in what people think about, okay, yes, we all agree that providers are an integral part to this, but how do we really get them to pony up to the table? It’s a question I ponder practically hourly. I would love some commentary on that.

TENNANT: First I’ll say ditto to Jean. I think WEDI is the perfect group, not just because they are named in the statute as an advisor to the Secretary, but that is an important part, so they have a reason for doing this and a track record. And ditto to Gail. I think we don’t have enough provider engagement in this.

Alix, to your point, there’s always the complaint that the providers are not at the SDO table, and our response is why don’t you come to us. Why don’t you come to a focus group that we could convene at our conferences? Not to point fingers, but CAQH Core goes out of its way to make sure that all of its discussions are telephonic so you don’t need to travel and have the cost. They’re very specific. They have fantastic background materials available prior to calls, and they make it as easy as possible. It’s still challenging, but it’s much easier than trying to get involved in the other SDOs, as well as the cost.

So there are ways to do it — focus groups, conference calls, open door forums that CMS could hold, inviting SDOs. There are plenty of ways to do it that we are not doing now.

COMBS-DYER: As a member of the HL-7 DaVinci Project, which is a public-private partnership that involves providers sitting at the table with us, I really want to echo what Gail and Deb and others have said about the importance of having providers. And for those providers that don’t have the time or the ability to participate, through the HL-7 organization we have been holding special open-door forum calls, like Rob just mentioned, to actually let providers know how they can at least participate in pilots and early testing as new standards begin to emerge.

BANKS: Obviously, I echo support with all these comments. I like the separation of the Call to Action B and Call to Action A because we all need to be accountable to identify best practices and mitigating the barriers and also working with the coordinating body to bring those to the industry.

But I was wondering if another recommendation could be added, and that is really talking about the business needs, the value, the ROI efficiencies, that clear, easy to understand message to providers of why. You know, we came up with 5010 and I don’t know if providers really understood what the value was to their business of moving to the next version. I know some of us vendors didn’t know. We just put in the standard.

So, as we get to small bite-sized pieces that we can digest, hopefully on a yearly basis or every two years we can talk about the value and get around solving the business need, like the operating rules are forcing us to do, so we have a common understandable language that providers know the value of the standard before it becomes mandated or before it comes into their workflow.

Again, it’s a different conversation, different message, but they need to buy into the use of these standards before they get implemented.

GOODYEAR: Obviously, from a provider perspective we agree with all those comments, and two points. One is that you are correct. This is not our playing field, so, to participate in that kind of a process takes us out of our comfort zone. We are trained physicians who care directly for the patient, and that is our comfort zone, and yet, we get involved with that.

One of the reasons that I think there’s a hesitancy on the part of direct patient care providers to be involved in it is I’m not sure that most providers understand the methods which the industry and the other stakeholders use to implement and develop the rules and standards. So I think there needs to be an education process. I’m learning here. This is as much a learning process for me as it is for me to provide any information.

So I think that if you can educate the providers about the methods that the other stakeholders use to develop and implement standards and rules. But I also think it would be really beneficial for you to understand the workflow in a provider’s office a little bit better than you do, recognizing full well that when we implement these standards, even if just temporarily, it interrupts patient care, and that’s what really affects us.

To us, it goes beyond predictability. It goes to what’s happening with the patient and our ability to care for the patient when these rules are established, implemented, mandated, and even if predictable there is still an interruption. I think a better education of what goes on in the physician’s office with these rules and how it affects patient care is important.

You can ask providers to come, but, as Brad said, it’s the IT people that need to be at our side when we’re here because there’s synergy in that information coming from the provider side, not just from the doc, but the IP people. Thank you.

JAFFE: I think the importance here is that the providers have much the same needs as everyone else, and although Tammy articulated it quite well, the bottom line is what’s in it for me.

The practical reality is that HL-7 created the Partners in Interoperability Program which brought together the providers to have a voice in this, not as a technical expertise but to articulate what’s in it for me. This has evolved into an initiative within HL-7 called the CIIC, which now has over two dozen specialty organizations not only of clinicians but nurses and therapists and dental practitioners, and they’re addressing the practical needs of delivering care, providing requirements that patients expect, and answering the question what’s in it for me.

HEFLIN: To the point about broadening involvement within the standards development process, in general, not just the few things we have talked about so far, there’s a real problem in the industry. Just on a personal basis I’m not sure if you’re aware, but a lot of us, myself included, make sacrifices to be involved with standards development. I make personal sacrifices. I have to delay releases on my software for change, which is what I’m doing for the next two days to even be here, and I have to pay for that as well. Not personally; my company pays for it, which means I have to also justify every meeting every year why there is actually a business justification for me even participating within standards development. And that’s for me as a technologist.

What about physicians? They actually may not even have truly a direct business justification for immediate ROI to them personally or to the organization to be involved.

So I don’t think this is enough. I think if we just continue to say we need broader involvement, we’re just not going to get it there. What we need to do is something concrete and actionable. I have been thinking about this for years, and I think the solution is pretty simple, that where there’s a national priority, the federal government simply should fund participation by named stakeholders.

For example, identify at least an academic, a patient representative or consumer representative, somebody from an engineering side, someone from a business side, someone from the policy side, someone from health information exchanges, someone from payers, someone from providers — basically identify the stakeholders we actually want to participate in the standards development process and then offer those individuals a scholarship to at least defer their fees so they don’t have to go back and make these arguments every year.

The situation we’re in right now, there aren’t very many organizations that could actually fund those — probably us, being here today — even participating with any standards. So if you really want to broaden the scope to bring in all those other parties, fund them.

GNAGY: I am in agreement. We are looking very short-sighted when it comes to what we’re discussing and the collaboration efforts that we’re discussing. I will offer an alternative to Eric’s solution, and that is community involvement, massive community-based involvement.

We see this across numerous other industries, wildly successful, and part of what they’re doing in these industries is they are able to not only interact with the community at large in real time but, on a massive scale, consider all of these community-based systems. There’s a list of them, and I don’t have my slides so I can’t show them all to you, but there are a number of community-based systems that offer significant involvement at the very low level, and numerous other opportunities are generated because of that.

You get a significant amount of data. You get data from the bottom up; you give them opportunities to add use case scenarios to explain these things. And then what do you have? Now you have this information, you have the people involved, and you are not having to pay for — My question to Eric would be who picks those people that get to sit there.

So the issue becomes, well, we need data, we need information, we need these people involved; how do we do that? Well, there are numerous successful scenarios out there that we can build off of where they’re getting real- time development information from these people in the trenches actively working, and then other professionals throughout that same industry are also collaborating with them and commenting and saying, oh, we’re doing something similar. Come check this out. And then these two people that would never have talked and will never get together are now discussing this.

Now consider you do that for five, six, seven, eight years, and you’re able to then take machine learning and AI and start building additional levels of predictability against this data that you’ve built.

So there’s a significant amount of opportunity that I think we absolutely have to get now, because if we don’t, if we wait until 2024 — I know that’s fluid, but essentially we’re talking five years out — what’s going to happen in that five years? If we don’t consider machine learning and AI we are already dead. We are already way behind the curve. And if we don’t get community involvement where we can get enough data to make that accessible, we’re going to be way behind the curve.

NARCISI: I totally agree with what Dr. Goodyear mentioned about the providers not being able to or wanting to be at the table. It’s a fact. If you ask a dentist they’re going to say, I don’t know what a 5010 is; I expect it to be part of my system. So they really go to the association and we represent the members.

One flaw, though, with that probably is that I can go to a standards-developing organization but I am not going to get a weighted vote, that I’m representing 161,000 individual members. So I think there’s a flaw with that.

But the other thing I think you need to consider is you need to look at the covered entities under HIPAA. I think some of the groups that are not covered entities really need to be considered as covered entities. I’m talking about, let’s say, worker’s comp, the vendors, the clearinghouses. So I think you need to pull them into this whole thing.

CAMPBELL: In my experience with standards development, there are kind of these three main phases where there’s the nuts and bolts of the standard itself and which little piece goes where, and that’s usually established by a lot of phone calls and emails back and forth. And then there’s the second phase, which is kind of the implementation guides and the profiles that explain how these transactions will be used and in what order, and a lot of that comes out of testing. And again, it’s technological, but it starts to bring in more of the workflow pieces.

And finally, there’s that last mile, which is how do systems that have successfully shown compliance with the standards actually get put into practice. At least in my experience it’s that last part that has been a little more free-form and kind of up to the individuals, and where the partners in the interoperability effort or other efforts could start to address that, there may be some opportunities there.

I think what’s important in this, though, is that it’s not necessarily the case that every single one of us needs to be at every single table at every single meeting throughout the process. As long as we have tight controls over the goals and the part of the process that we’re focused on in that overall standards lifecycle, I think we can really target the involvement of the stakeholders to the part of the process and maybe try to get some better use of people’s time throughout so that we can get providers at the table when it’s appropriate and when they can create the best contribution.

LOVE: I think we have run the table on this one. Oh, two more.

MUIR: Chris Muir from ONC. Just a couple of thoughts. First of all, I wanted to echo what everyone else was saying about including providers and other stakeholders into the process and finding ways in which to make it easy for their entrance into those processes.

One thing I think may be missing, and maybe we haven’t gotten to it yet or I have overlooked it, is the dissemination of the best practices and the adoption. Maybe spending some time thinking of ways in which, after those best practices are identified, we disseminate that and how do we encourage people to adopt those.

ALSCHULER: I am really encouraged and excited about the breadth and creativity of the ideas presented here in terms of provider engagement. I will just add briefly that, again, it’s this concept of collaboration and how to make that feasible.

We have to look also at the number of points at which provider engagement is required today, because there’s engagement with terminology organizations, there’s engagement with different SDOs who all have overlap in terms of provider interests. There’s engagement with this committee, NCVHS, for your recommendations. There’s engagement at the regulatory level.

So, if this becomes a more unified process, then it also simplifies and makes more feasible the engagement of providers because whatever we imagine in terms of incentives or payments, which we can do and make it directly of interest, it can’t be at four or five different points in the process.

LOVE: Thank you, all, for keeping us on schedule. We have earned a 10-minute break.

GOSS: We are going to give until 11:30.

LOVE: There are some snacks in the back. Get additional drinks and we will promptly start at 11:20 with the next call to action.

(Break)

LOVE: We will take off where we left off. Call to Action B, I don’t think we need a lot of time on this one because we covered this previously. I just wanted to underscore that the call to action is that the Workgroup for Electronic Data Exchange, or WEDI, through its workgroup structure, should continue to identify issues and solutions and publish white papers advising on agreed-upon policy implications and best practices related to the use of HIPAA standards and operating rules.

We heard in the discussion that there’s a lot of concurrence on this, as WEDI has been a longstanding convener and brings diverse players together in the healthcare ecosystem and has this infrastructure already in place. I don’t know how much more discussion we need on this.

I do see a couple of cards up.

HEFLIN: I would just very briefly emphasize one key point. I think all of that is true, but also, to re-emphasize, I think WEDI and other organizations playing the role of an SDO in the industry should be funded to actually create reference implementations as well, which will reduce barriers and friction for adoption.

WEIKER: First and foremost, I want to say that NCPDP supports the missions and goals of WEDI. However, WEDI’s white papers and guidance typically focus on the medical side of the healthcare space versus the pharmacy side, and NCPDP identifies the issues, solutions and publishes white papers advising on agreed-upon implementation guides and best practices related to our standards and our operating rules for prescribing, dispensing, monitoring, managing and paying for medications and pharmacy services.

BANKS: More of a question. This is kind of a gap that I think we have, and again, I don’t know if WEDI is the appropriate party or not. I’m just raising the gap, wherever it should be filled.

You don’t go to school to become an industry representative. There’s no leadership development. I know there are leadership growth patterns in different SDOs, but again, where is that general — you know, when you look at the clinical side, you know that it was funded, education on health IT, funded value-based payment, education for providers. Where are we really trying to grow and get the expertise?

I know there are some people who have a wealth of expertise across all these standard transactions. How do we get more of that type of leadership to fill these roles, because, unfortunately — we’ve got to commend everybody who works with standards development because these are thankless jobs that they’re doing at home, missing time with their families because they’ve got real jobs, too. Not that that is not a real job.

So, growing of leadership positions as well as we’ve got to think about incentives. I don’t know if funding the SDOs or different types of incentives for the leaders to continue to get the — I hate to say younger people — to get more of my peers involved in this work so we can continue to innovate. And Brad is talking about communities. This is mainstream language for my son, and we’re not even in the real world of IT when we start thinking about all the possibilities that are out there. We have got to grow volunteers, leaders.

COMBS-DYER: I just wanted to let folks know that Medicare Center for Program Integrity supports SDO partnership initiatives, like HL-7’s DaVinci Project, that have specific use cases and are focused on interoperability like the coverage requirements, Discovery and e-Health record exchange.

We are happy to provide support to any other SDO that has that kind of partnership that can come to us with those kinds of use cases. And for the right idea or initiative we can also provide contracting support for those kinds of things.

BEATTY: We also support the efforts of WEDI, but WEDI is not the only place where some of these things need to be discussed. As pointed out, NCPDP has their initiatives going on within their groups. X12 has other initiatives that we conduct periodically looking at innovation and other uses.

I think, again, looking at more collaborative type of efforts, different groups looking at different lenses of how to address various issues within the healthcare industry. It’s a collaborative effort.

TENNANT: I certainly agree with Gary. I think the one thing that strikes me is maybe a little more collaboration with CMS in terms of identifying concerns that they have, especially in light of our earlier discussion —

GOSS: Rob, do you mean CMS, the Division of National Standards, or the Melanie side of the house and the fee-for-service and Medicare Advantage?

TENNANT: Probably more the Division of National Standards. When they’re looking at developing policy, I would encourage them to reach out to WEDI. I think WEDI acts sort of on its own accord because there isn’t a close enough relationship with CMS.

But to Margaret’s point, if CMS comes and says we want to look at issues related to pharmacy, then you bring in the other key stakeholders like NCPDP. But I think there has to be that more aggressive relationship so we can identify the barriers that CMS is seeing.

LOVE: We will go to Slide 20, Call to Action

These are excellent comments and they are being duly noted so I’m enjoying the discussion here.

The SDO should consider collaboration with the private sector to plan and develop outreach campaigns with the intent to increase the diversity of participants in the standards development workgroups — I think we touched on this in some of our previous discussions — and to be sure that the standards are updated that reflect technology, business changes. SDOs must be a reflection of the organizations they serve.

I think the challenge we heard is getting the provider voice in there, but I would also advocate that in recognition of the broad uses of the transactions there is also quite a bit of state and public health voice, and both of these practitioner groups have constraints like many of the others to full participation. But this call to action is increasing the diversity of participants in standards development workgroups.

I open it up to comments.

WEIKER: NCPDP has a few things that we do in regard to collaboration. Most of our work happens in what we call our task groups, which meet via teleconference.

Anyone can join those; you do not have to be a member to participate. We have a website called our collaborative workspace. All of the task groups have a space for that where all the documents, minutes, notes are placed to where anybody can go out and look at them. You do have to register, obviously, but you don’t have to be a member to do this. You can actively participate in the task groups without membership in NCPDP. And then the work from that task group does move forward through the workgroup through our processes, our ANSI-accredited processes, to then become a standard.

Also, we have entities that will bring to us an initiative. Recently, the specialty pharmacy subsection of pharmacy came to us, so we actively went out and recruited specialty pharmacies — the actual pharmacy, the provider, the vendors that build the software for those, which is different than your retail system, and then the payers that have specialty pharmacy and pay, and it’s a little bit different.

We have a multitude of ways to try to ensure that we get all industry stakeholders at the table, and we would actively go out and recruit organizations, companies, even individuals to meet those needs that we get presented with.

GASH: I just want to say I support the intent of this comment. I would encourage you to look at some of the professional associations as a vehicle to get broader collaboration across different groups. The MGMA, the AHA, CHIME, HIMS are representing diverse groups and large groups of stakeholders here and could be a mechanism for you to get broader involvement.

I also think there’s great work going on in various groups. We have heard about the DaVinci Project with HL-7. Those collaborations with groups like that could help you in establishing testbeds and validating potential new standards and bringing back feedback. I think the intent is good here, but I would just look more broadly at perhaps some of these organizations that are already doing some of the work you’re wanting to do.

JAFFE: I think it’s worth applauding DaVinci for the work that they have embraced. I don’t think we should lose sight of the Argonaut Project, which, four years ago this month, began the first major private sector collaboration without any funding and brought in provider organizations as part of an integral collaboration.

This has been continued. We now have opportunities beyond the DaVinci Project which include collaborations in genomics, population health, non- regulated clinical research and other areas that are on ramp through our standards as a service program. This initiative is taking a large swath of providers in the private sector into a collaborative community.

CAMPBELL: I just wanted to say it is certainly understandable how a lot of these organizations need financial contributions in order to stay solvent, and certainly we try to sponsor as many that we think are doing good work. There are sometimes when you want to be able to contribute in some manner, and even if that is not financial, I want to appreciate those groups that do open up the opportunity to contribute with work. It’s certainly understandable that that would not be a voting position, but even opportunities to participate and contribute to the cause in kind have been very helpful.

TODD: Just a ditto for Deborah, thanks.

WEIKER: I just wanted to comment and add some detail to a comment that Rob had mentioned earlier just around Core’s process. I think there are some learnings there that could be extended across the industry. I just wanted to comment on how our process generally works to make sure that we are engaging broad swaths of the industry.

When we start working on a topic, we conduct a pretty extensive environmental scan, and one of the things we do is make sure that we’re going to providers in particular and watching and evaluating how processes are working within those particular environments to make sure we are understanding that.

And we also have a process where we work to engage individuals from the plan, provider, vendor, government entity perspective and the SDOs as well throughout various stages of development, including at the beginning stage which is around advisory development or the policy development around which areas to focus on, all the way down through our subgroups and our working groups as we work through rules and throughout that process that we have through voting. We have roughly in each set of the rules that we have developed 40 to 100 different organizations that are participating in those groups, and work to get a quorum with each stakeholder group that is participating to make sure that we have broad consensus.

Throughout this process, the feedback that we have gotten across the industry is that that process of going to providers, making sure that we are engaging various groups throughout the process, has helped Core’s process to both make sure we are getting broad perspectives as well as accelerate the development process.

BEATTY: Gary Beatty with X12. X12 welcomes anybody to participate in their process regardless of whether they are members or non-members of X12. We look to bring consistency within various stakeholder groups to bring their needs to the organization. We also hold caucuses, similar to what Margaret mentioned earlier. We have different caucuses that represent the provider community, the commercial payer community and other stakeholder communities within X12.

We also welcome the provider participation from other organizations that represent that community, including the ADA and AHA.

As we have gone through these definitions — and, Alix, you pointed out earlier some of the feedback you are looking for is, you know, we all talk about provider participation and earlier we heard talk about clinicians and so forth, and I have had the opportunity to spend the last couple of months on-site working with providers.

I think the interesting question is providers will have different lenses on what we need relative to these standards, whether they’re the actual clinicians providing care, because clinicians don’t go to medical school to learn how to run a business; they are there to provide care to our communities. But we always need a better definition of what a provider is. We say we want provider participation. Is it the clinicians? Do we want the clinical system type of folks that participate in the clinical systems, the administrative systems? What really is a provider? Do we have a really good definition for what that is to be able to participate in our organizations?

Certainly, we have different levels of information we need to share with all of these various groups, but we have to figure out who do we really want to participate and at what level do they participate.

ROOSA: First, I just want to ditto Danny’s ditto of Deborah’s comments. I think it’s a very important way of reaching out and getting a good representative of the different stakeholders by going to the associations and working with them.

In terms of the comment about who a provider is, I guess we could have a debate. In my mind it’s clear that a provider is an entity or a person that is providing direct healthcare services to other human beings. But who that provider sends as a representative could be anybody, certainly. That would be up to the provider, and that provider would then be represented at the table.

GNAGY: Triple ditto. The trusted advisors of the providers are who we’re talking about — I have very few providers that actually know anything about the standard or how it looks or what its function is other than from their standpoint. So, agreed, the people who the physicians trust to get those things done need to be at the table.

But I continue to hear things like large and most. I have yet to hear somebody say all, and I think that is the important element. We’re not talking about all the industry; we’re talking about large swaths or big chunks or this organization or association. I really think that the future is the communities, is the outreach and is the methodologies that allow people to interact with your product, and the product that we’re discussing is standards. And right now, there is no way for people to interact with your product other than what we’re doing here. There is no direct way.

And the innovators want that. They don’t want you to dictate — come here and talk to us and we’ll make these changes. What they need is direct interaction with the products. They need to be able to be given access to innovate, to discuss this with people, and it’s becoming more and more real to the people in this industry that they need those things.

I can tell you that when I design an environment for my millennial programmers to work within something that’s very comfortable for them, they produce like rock stars. If I stick them with my older programmers and put them in a room and they start having waterfall type discussions, everybody wants to kill each other.

You have got to establish the environments and you have got to give the people consuming your product an ability to interact with it; otherwise, what you’re telling them is our product is X. If you need Y, go figure it out. Not, if you need Y here’s the place to go to do Y. What we all want to know is the actual Y, not the why. We want the one-offs. We want to understand that. We need to get that data and we need to then assimilate it, and have it open for discussion.

So, when we hear things like broad swath, that’s great, but the reality is if we don’t start talking about all participation, all collaboration, we’re going to be behind.

LESTINA: Just a clarification in terms of the NUBC. The NUBC is a data content committee and we have a diverse group of healthcare industry stakeholders representing a broad range of stakeholders, similar to other organizations that have mentioned how they operate as well. But I just want to go back to the comment that Arthur made about I think we all can define a provider.

But I think the key part is who, and maybe even going back to something that Janet I think said in an earlier conversation about tiers. There’s the difference between the representation of a provider from the IT perspective that might be part of the creation of the “what” and then, ultimately, it’s in the hands of the folks who have to operationalize the what and it’s the how it gets done. I think sometimes what gets lost is that on paper, electronically, this looks awesome, but when I have to operationalize it it’s a disaster.

I think maybe that’s where we really have to make sure that we’re including it — not only that there’s provider representation from an IT perspective, but we’re getting down to the folks who actually have to use those transactions, to make sure that we’re using them the right way and reduce that burden that it’s supposed to be reducing. We need to be thinking about that as well.

GOSS: Thank you. Yes, practice administrators is not a term I have heard used yet today, as somebody pointed out to me in the audience, but they are an integral part of the process. Joe, you are up next.

BELL: I think this is a little bit about how everything is intertwined. Perhaps part of the participation challenge is the issue we have with intellectual property of the various organizations that own it. I can tell you that significant funding is based off of that intellectual property since they aren’t funded any other way, and the industry has to basically finance that intellectual property. That goes everywhere from code sets to operating rules to standards.

Also, the distribution and the way that we can share this, because that’s what this intellectual property causes some roadblocks with, such as when we come out with a standard we basically put it in a document format. We call it electronic because it’s a pdf, but it’s basically our version of a book. If we could improve the way that we distribute and are able to work with that. Open source coding is prevalent when we talk about — Brad talks about communities and everyone contributing. It’s because they make the delivery mechanisms, the work, the communication, the process all very accessible, and so, if people wanted to implement new technology, they can build on these building blocks.

So, perhaps the standards need to be more of a building block foundation rather than a directive that this is exactly how it needs to be done.

NARCISI: I just want to comment a little bit on the provider participation, and I think it’s probably a little different with dentistry. The ADA is actually an ANSI-accredited organization and we have a couple of different standards committees. One deals with instruments and equipment and there’s one that’s the standards committee on dental informatics.

What we have been doing for the last few years now is — and that standards group includes the dentistry vendors, payers, the government — we have been identifying certain things that we want to be able to provide the content with. We also have a good relationship with HL-7.

We have a statement of understanding. What has happened with a couple of the standards is that we were able to take them — for instance, the attachments — take them to HL-7 and our content was already defined so they did the magic with the implementation guide. So it really did have the provider input.

Now, looking backwards, that wasn’t happening with the original HIPAA standards but hopefully in the future that will happen again.

GOSS: Mark?

GINGRICH: I wanted to affirm Brad, and I agree, we have to do more that gets into the community. That’s why we participate in Argonaut and DaVinci. None of the work there is done; the standards work isn’t complete until we have vetted it and it’s actually getting used. That’s why I think in the last go-round when we had this meeting, it’s important to be able to iterate a standard and iterate it in the industry so you can actually determine whether or not you have made the right changes to the standard or enhanced the standard in an appropriate way. I think we need to be able to do that. It’s that practical use within the industry and getting the input from providers and all which are part of the workflows that these transactions support is critical.

GOODYEAR: I personally don’t think it matters who the person is at the table, but I think there needs to be a strong collaborative agreement between my definition of the provider, which is the individual that’s actually providing healthcare service to a patient, and their support group, that being the practice administrator, the IT and staff.

I think the provider’s input is a synergistic collaboration between all of those members. Who actually comes to the table and presents that opinion I don’t think really matters.

GOSS: Next is Rob followed by Liora.

TENNANT: I wanted to support Suzanne’s comments. I think she is spot-on. When you look at these standards, I think we would all agree that the chance of a physician himself being engaged in development of the standards is very low. But they understand the potential impact on their business as a business owner, so they would certainly delegate the issue to their RAV, new cycle staff, their practice administrator, the folks that do the billing. And those are the folks that are at ground level who understand how these transactions work in the real world.

I would argue that this issue bleeds into one coming up later, which is the establishment of ROI and business need, because a standard may be technically proficient but it’s a solution searching for a problem, and I think we have faced that in this industry in the past.

So I think what we can do as an industry is engage providers where they are but also at the operational level so they understand what the impact of a change would be, get that input, and that will help us establish an ROI. Because it’s easier for us, quite frankly, as trade associations, to make a case to our members why we need to move to 70/30. But if we don’t have a business case, it’s a hard sell for them to spend what they always tell us is their child’s college fund on upgrading their systems.

ALSCHULER: I want to echo what Jean said about the effectiveness of professional societies representing the requirements of their constituents. It’s a very effective model EDA has used, ASCO has used. However, many professional societies today don’t understand that synergy and that they can engage in that manner.

But I also feel it’s important to look at the word diversity apart from the clinical classification that’s implied here. I just want to put on the table the meaning of diversity that it might have outside this group, which is to make sure that the diversity of populations served is well considered — rural, urban, socioeconomic status of population served, ethnic and racial background –

– because having a diversity of providers who are serving those populations is also going to reflect the kind of requirements that they see day to day.

Finally, I know CMS is making a major effort to ensure that in value-based care the voices of persons, patients, caregivers are reflected in quality measures. And I wonder if there’s a place — and I don’t want to bring in a big hornet’s nest there, but — if there’s a place for what is sometimes called the consumer voice or the person receiving care or their caregivers.

GOSS: We have one more card up. We still have one more call to action in this section, so we are going to ask for your flexibility and let’s wrap up the last call to action — oh, the card is down — and we will then go to lunch and come back with Rich Landen leading the next section.

LOVE: This call to action is really related to the one we just discussed and it really speaks to increasing diversity in the process. The call to action is: Leadership from the public and private sectors should commit to membership in the SDOs, assign appropriate subject matter experts to participate in the development and update process, and facilitate this.

I also would add, and the challenge that I have seen in my world in the public sector is, even if you engagement and get that leadership, sustaining it. That is a real challenge.

The SDOs may need to reach out — we heard commitments to this — to the private sector but also the public sector to increase this diversity and issue response for volunteers.

DARST: According to our multi-stakeholder group, this is definitely a challenge, and they felt that support is needed by HHS and the government to kind of push different groups to participate in the SDOs. We don’t know how else that will happen unless there’s a push by the government.

GOSS: That’s really indicative of how much people only act when responding to a hammer that comes down in a regulatory or policy framework.

WILBANKS: Participation in SDOs, from our perspective, is often the case of, okay, I’m going to devote someone to work on a standard that I might be able to do five years from now or at some undetermined time in the future, or I can take that person and I can have them develop functionality that I can definitely implement this year. That becomes a very hard sell for me to go up and say I’m going to want to take that person and actually put them on this item that we might do in the future.

So, really from the SDOs, I think this call to action is a little early in that we need to have a better roadmap of saying definitively this is when you’re going to be able to implement these changes coming out of the SDOs, if you really want to get leadership to be able to buy in and commit people to go there.

COMBS-DYER: Just for the record, CMS does believe in putting patients first. In case you haven’t heard that, that is a really big initiative for us over the last year or two. Just one example of a place where we’re doing that is actually going on listening tours and putting out requests for information — we call them RFIs — really trying to get input about what it is that patients need and want from their medical records.

If you have not heard Administrator Seema Verma talk about her story of her husband having a health event and ending up at the end of the hospital stay with five sheets of paper and one CD-ROM., you will know she really is passionate about this. She really does believe in patients being able to get their medical records.

One specific example of how we are trying to begin to really incorporate the patient’s need for health information and interoperability is we have heard that patients want cost information, they want price transparency, and CMS has been working really hard on trying to provide that.

We are now discussing on the DaVinci team whether it would be possible to add cost information into the coverage requirement discovery use case. For example, from the EHR when the provider is going to look up the coverage rules, could they also look up the cost? What better time for the patient to learn that the oxygen is going to be too expensive and they’re going to be noncompliant? Why not discover that right in the doctor’s office?

We really do believe in this. I’m not sure if it’s going to fit into the coverage requirement discovery use case or if that’s going to move to some other use case, but we really do believe in involving the patients in this conversation.

SAWYER: Part of the predictability roadmap we understood, too, is trying to get things out to meet industry needs. Based on even what Rob was saying, so, not a problem seeking a solution, or a solution seeking the problem rather. But if we’re going to meet the industry needs, yes, we need the industry to come to the table and say here’s what our needs are so that we can address those.

I think I’m hearing some discussion about the government driving that, and I would rather the industry and the need drive what we’re doing rather than the government defining what that need is.

BANKS: I have no problem with the call to action; I just want to respond to your comment. But you know it’s this thing, if you do something in the same way, you’re going to get the same result. You heard about DaVinci, HL-7 — the amount of people that come to their annual meeting. I’m sure the other organizations have the same thing. We have got to re-invent what we’re doing in order to encourage participation, and ten years for a new standard is not going to get participation.

So, mandating leadership to say, hey, you’ve got to send people — we need a business case for why. And it’s not the SDOs’ issue. This is our industry issue. If we’re going to move something forward, it has got to get mandated. You can’t keep pushing it back. Because, again, you’re investing resources and there has to be value and it has to be a business need.

And just to reiterate, like DaVinci, you’re getting money to the table and you’re getting participants to the table to solve a particular business need. And it’s not maintenance; it’s actually solving and innovating, testing, reinventing with continual process improvement, that CPI. That’s kind of the challenge with the statement that you have. You can’t just continue to do what we have done since HIPAA.

GNAGY: Just thinking of standards, part of the goal here is to come up with a standard on a basis that we can all ingest properly, and I hear a lot that it’s 12 months, it’s 24 months, whatever the case. What is that timeframe going to be in five years? Is it going to be significantly lower? Is there going to be a lot of other technology that’s involved with this? And the answer is yes. But can we predict what that is? Not really at this point.

I’m going to go back and repeat myself again, but if you don’t allow the consumers of your product to interact with it, they are not going to want to interact with it. They’re going to go out and find their own methods. The communities will get you data, but the simple fact is if no one is interacting with your product and in real time in solving their problems, they aren’t going to look for you or your product to solve their problem.

I strongly feel that adding an extensible unit to these standards is an absolute necessity, and it also leads us into the additional opportunity that now you have an instant way of showing the community how to interact with you, and then you start setting up these communities.

BARLOW: I primarily want to ditto a little of what Brad said. But in truth, this call to action tends to follow as opposed to lead. If the overall objective here is to make this more an Agile process, a more quick-to-market process, when you start to do that, when you start to put the right kind of tools in place, you will bring those people to the table.

You can’t kind of force me to the table to eat a meal that’s going to take five years, but if I’m seeing that something is going to be changing every year, I’ve got more of a reason to invest in that. And if I have an easy way to do that, I’m going to be there faster.

It’s kind of like there’s a cart and a horse here and which one is going to drive the train. But you will get more participation by having a more diverse project plan and an Agile development process. It’s just going to come by nature. If it’s going faster you’re going to want to stay in touch with it, you’re going to stay in tune with it and you’re going to participate more actively.

GOSS: It certainly does sound like there’s a lifecycle that we need to create, and that reinvention comment that Tammy made about getting people to the standards body, having it be affordable and not having IP barriers for adoption and creating the incentives, having everybody knowing that they’re going to have a bite-sized investment that they need to make to get the return in a much faster way is what I’m hearing you say.

BARLOW: Yes. And the open source comment made earlier is absolutely a true add to that lifecycle.

COUSSOULE: One comment just from a practical experience standpoint having taken an organization through a transition into an Agile process. It sometimes seems relatively easy, like you could do that in isolation, but you can’t. And it involves virtually everybody in the cycle before too long to see that kind of value.

So it’s not a caution, by the way; I think it’s a really good transition, but it is a very challenging transition because it’s as much a cultural shift as it is a practical shift. So I just ask you to think about that as you try to think about how fast you can move and what you might do in that regard, because it is a big cultural change as well.

MIKKILI: Kaiser Permanente definitely supports all the standard development organizations, but it becomes very challenging to actively participate in all these workgroups. Most of the time our participation is based on the business requirement, such as right now it’s the claims attachment. So I request that there should be a roadmap or a structure so that we can actively participate in all the workgroups.

BELL: I would like to take everybody through a little story of the lifetime of a standard development organization volunteer, and I’m going to speak specifically to X12 because I have the most experience with that.

Basically, you are really good at your job that you get paid for and you understand EDI. And to further understand it more, you get roped in by saying I could learn more if I go to an X12 conference, because it’s a conference. Then you go to the X12 conference and you immediately realize this is a lot of work, but I’m good at my job and I want to learn, and I want to get involved because I care.

So then you start putting in requirements and working in the task groups and the workgroups and this and that, and you get recognized that you are a really good contributor. So then they tell you, you know, we need workgroup chairs —

(Laughter)

And you get volunteered for more work as a workgroup chair. And because you care and because you’re good at your job, you go ahead and be a workgroup chair.

And then there’s more responsibility as you show that you’re good at your job and that you care to the point of, wow, I have this job that I’m getting paid for that’s paying for me to go and do this complete other job. That’s a tough sell.

So, to your point about leading a group to an Agile environment, I have done the same. It is not an easy process. I tried to explain the process to my wife. She told me it sounded very millennial, so I probably didn’t describe it well. The longer we delay, the further behind we are.

So I think we just — really, the system is broke the way that it is now. I think we wouldn’t have meetings such as this if it was not. I applaud the efforts of trying to understand the ways to fix it, and it is going to be a process, but we need to get started quickly.

GOSS: Thank you for that bit of humor and the no good deed goes unpunished story.

GNAGY: Speed is definitely of the essence, and I will be the first to admit my first attempt in moving our developers into Agile was an abject failure and easily one of my worst disasters.

But the fact is that you don’t lead the IT people. You don’t say, okay, here’s the door; you walk through it, you go there, you help these people, you talk to these people, and this is how you do it.

The way I deal with my people — and it’s much more constructive and gets much more out of them in a way that they want to do it — is I say there’s a door; that door helps with what you’re doing. You go through that door and you can work within there to fix it. And then I just give them the code to the door. I don’t say go there, I don’t say this is how you do it. I show them — here’s where you go, and they go do it.

If I try to micromanage them, if I try to go and say okay, we’re going to have all these higher-level groups that do these things, it’s a nightmare. You can leverage the smartest people in the industry this way. And I’ll tell you I am not that. I’m not the smart people in the industry. They are the guys who work for me. They’re the guys that are out there saying hey, Brad, this is how we solved this solution, and then they explain it to me and I go, that’s super.

What I would really like to do is say here’s where we work — we primarily work within X12 — here is where we work, and here’s the door. You see that little extensible segment there? You can do whatever you want with that. Go fix all our problems there. And that is also attached to CMS, also attached to everybody else. When we put our stuff there, when we tell you what there is and what we have done there, you know about it and everybody else knows about it. Then someone else goes, hey, we did something just like that and this is how we did it, and we put it there, too.

CAMPBELL: On the comment on Agile development processes and Agile processes and standards development, that certainly can be a really useful tool for refining the details of the standards. I just wanted to point out what I’m hoping is in the back of everyone’s mind, is that organizations, of course, don’t upgrade on an Agile development cycle. And so, as we look at the overall finalization of those standards, we should keep that in mind lest we be patching software every two weeks.

WILBANKS: Since we’re discussing Agile, having gone to an Agile shop, the biggest lesson learned is if you’re going to Agile there should also be a willingness to walk away from a mistake. Agile assumes that you’re going forward, you’re doing development even when you don’t have the full picture, and I’m not sure how that would fold into the current standards process where we look at it and we say yes, that looked really good on paper, we sort of went ahead with it, we looked at it and, no, not really, we need to walk away. I’m not sure how that will fall into either the X12 or the WEDI flow, to be able to do that.

GOSS: Denise, I see no further cards up.

LOVE: This is where I get to do the lunch part, but my Chair tells me what time we want to be back here. Is it 1:20?

GOSS: Yes.

LOVE: At 1:20 we will reconvene and we will appreciate your being back on time so we can dig into the rest of the robust discussion.

(Luncheon recess at 12:20 p.m.)

AFTERNOON SESSION  (1:20 P.M.)

GOSS: We want to go ahead and get started with the next portion of our meeting. This next section is going to be led by Rich Landen. Hopefully, everyone’s ready to jump into the next round of good topics.

Agenda Item: Discussion of Outcomes Goal 2 Process Improvements – 9 recommendations & calls to action

LANDEN: Welcome back and I hope we continue the productive discussions like we’ve had this morning.

Again, just a word that this is a draft we’re putting out for reactions, so reactions are welcome, supported. Whether you agree with us, disagree. The process is a long-term set of actions to improve things across the industry, so as long as comments are delivered in a spirit toward that goal, they’re absolutely welcome and we want to hear everything you have to say wise, otherwise, good, bad, and the like, as long as it contributes to the outcome. So, thank you in advance.

On this slide, Outcome Goal 2: Process Improvements, we had talked about policy levers that will support the processes necessary for improvement. We discussed earlier that our working assumption was for the recommendations to be completed or near completion or substantially begun, in the years that are specified in the tables with the recommendations. There are nine recommendations, calls to actions, and measurement elements in this Section. Five of them pertain to the concept of evaluation oversight or what we’re calling stewardship of the maintenance and modifications processes for standards and operating rules. And that’s at the core of the predictability that the subcommittee and NCVHS are shooting for.

The other four recommendations, calls to actions, and measurement items, are process related. These address regulation timing, health and human services operations, certification, and NCVHS hearings. These policy levers are intended to support improvements in both industry and federal processes, that in turn will be responsive to business requirements.

Outcome Goal 2: Recommendation Number 3. Let me read this for the benefit of those who may not have visual access. HHS should disband the Designated Standards Maintenance Organization affectionately known as the DSMO, and work with its current members for an organized transition.

Let me give some background before we get into this discussion. Let me also point out right up front that this recommendation is closely tied to Recommendation 4, on the next slide, that talks about a transition to a successor organization. So, this is more a transformation rather than the harsh language that this slide, taken by itself, might about disbanding the DSMO. We’re really talking about a transition. But we had to parse it and such into digestible bites, so we divided into those two things.

Now back to the background. Shortly after HIPAA was signed in 1996, an approach was designed to oversee the way change requests for the adopted HIPAA standard transactions would be handled. The belief at that time was that a centralized approach would promote trust. Again, that concept, going back to ’96, ’98, the trust was not a given.

We’ve had a lot of experience in the 22 years since then and I’m happy to say that I think there is a lot of trust. But at that time when the DSMO was created, the availability of trust was an uncertain concept. And so, we thought that funneling potential changes through a centralized vetting process would support administrative simplification efficiencies and standardization and achieve that balance of viewpoints among the different impacted entities that have been referenced several times, in several different contexts, this morning.

The HIPAA statute, that is the law itself, required the Secretary to consult with certain named organizations. There was the code, the content committees, the NUBC, the NUCC and the ADA, as well as WEDI. It also required consultation with standard setting organizations before adopting a new or modified standard. The SSOs were not named in the statute but NCPDP was listed as an example in the statute.

On July 24th, the year 2000, HHS published a regulation naming the Designated Standards Maintenance Organizations who were to evaluate the updates to the standards and code sets. A formal process for the review was created through a memorandum of understanding. This process became known as the DSMO process, and again, an MOU is not regulation. An MOU is a voluntary binding agreement among the entities that are signatory to the memorandum of understanding.

For the first five or more years, industry stakeholders submit a change requests for each of the standard setting organizations to the DSMO website using the process established by the MOU. Sometime in the mid- 2000s, 2006, stakeholders began to submit more of the change requests directly to the applicable standards setting organization. As required by the process, the final request for approval of a completed published version of a new standard came from the SDO or the SSO to the DSMO for submission to NCVHS.

In 2010, with the requirement for the Secretary to adopt operating rules, the operating rule requirements did not set things up. So, the operating rules do not go through the DSMO. Let me open it to questions or comments about that. Again, we’re tying this, not just to disbanding the DSMO, but to replacing it with something that reflects the current state of the industry and the current state of standards setting, development, data content, and looking more largely then, is the convergence of the administrative and clinical systems incorporating the work that NVHCS and others are doing on terminologies and vocabularies. So, there’s a lot coming together.

NARCISI: Jean Narcisi from the ADA. I’ve been a participant in the DSMO process since its inception. I believe now at this point in time that it should be disbanded. I think it was very, very useful in the beginning. Rich laid out a whole lot of history there. Many of you won’t remember, but there was this thing called the fast track. There was not enough input, I believe, in the first go around in the development of the HIPAA transactions. I think it was probably because organizations didn’t really realize what was going on and didn’t have the people that could commit to it. So, once it was named, there were, I think, over 1,000 different change requests that needed to be processed and that was all done through the DSMO process.

Now I believe that the standards developing organizations do have more of a balanced representation, and the standards are handled differently. I do think though that a new entity should be formed, and I also believe that, as a steward, I believe it should be WEDI that oversees this because they work in an environment right now where they have all of the stakeholders involved. Probably the makeup of the committee could probably include the organizations that were named in the statute, but with a lot of other experts including the operating rules, which aren’t included in this DSMO process.

But there needs to be some financial support for that to go on. NCVHS still needs to be involved. But the biggest burden that is holding up everything is the regulatory process. So, there has to be some way that, that organization, the new entity, can move out standards without having them to be named through the regulatory process. And I don’t know how that will all work, but that would be what I would suggest.

In my written comments, I wrote quite an extensive way that perhaps maybe this could be handled. They would review existing standards. They would have to identify the compelling need for new and updated standards, looking at the business needs and doing a cost analysis on what that would be to update. Maybe it’s even looking at a new policy or a new standard or a guideline. Looking at the review cycle and then that should be no more than two years. And then also, focus in on also reviewing, approving, and maybe expiring some of the standards. So, that’s my suggestion.

BURCKHARDT: Thank you. As I mentioned in introductions, my name is Laurie Burckhardt. I’m the current chair of the DSMO. I represent X12N on the DSMO committee. One of the things is, thank you Rich for clarifying, going into a little more of the DSMO. I think one of the things from the DSMO all perspective that we had issues with was it didn’t work. The DSMO doesn’t do what it’s supposed to do, and I think we have done exactly what we were supposed to do based off of what we were charged back in the early 2000s.

A lot of work was done, as Jean has already mentioned, with the thousands of change requests that come through. One of the things I think is a lesson learned, as you educate the industry though, they did learn who to go to, where to ask, to get their changes made. So, I think that this shows that once the industry learned that, oh, it’s an X12, I need to go here and submit my change request or file my business use case. I need to go to HL7, I need to go change a paper claim form. So, I think that this proves that education does work to the industry, as just getting the word out and getting the repetition out.

As far as the disbanding, if that’s what happens, or you regenerize the DSMO, you do need to add additional players. I don’t think the players are big enough. I think what we need to bring in, part of the discussion was bringing in other members. It would be nice to have one flow, as you move things forward for recommendation, that whether it’s an existing standard and you’re doing a new version or it’s a new standard, like an attachment. Those would come through the same entity.

The committee was including operating rules in the same process because as part of operating rules you want to make sure that they work well with the standards and this could be a way to keep things in line so that you’re not working a step behind everything. You want to make sure operating rules are going with the standards moving forward.

LANDEN: Let me just add, to reiterate, that the DSMO was designed and intended to do certain things at a certain stage of HIPAA development and I think DSMO can well declare success. And it’s time now to look at redefining what the DSMO’s role was in light of where the industry is now and where it’s going in the next decade.

SUAREZ: Thank you. I think with respect to these recommendations we are in agreement. I think the need for what used to be an important role, called Designated Standards Maintenance Organization, is not there anymore.

So, I completely agree with these recommendations. Where I think is going to be important to go to, is really the question of, do we want to replace it, or do we want to not have any such organization.

And the reason I say that, is because, yes, at the early stages of the process for adopting standards this was a good vehicle to bring together the standard development of organizations involving the HIPAA transactions. In today’s world, it’s not clear to me what role the new organization will play. And in fact, my belief is that it would add another layer, or in this case replace, this layer of the process for, once a standard is completed, moving it through the adoption and implementation stages.

Now if one compares, in parallel, the experience that we have had with the electronic health record standards adoption process, there is no DSMO or DSMO-like entity when it comes to adopting or has been the case for adopting electronic standards for EHRs. There is an advisory committee, there is other elements, but I don’t believe there is that type of an entity that has been used in the adoption of standards for electronic health records. And so, I believe that at this point we have fulfilled the need for this organization and I believe we’re ready to move in a more agile way to adopting standards.

WEIKER: NCPDP agrees that the DSMO has served its purpose and should be disbanded. In the beginning, the DSMO performed an important function managing the HIPAA standard change request process in coordinating activities of the standards bodies and the data content committees. Currently this coordination happens among the standards bodies and data content committees, with their respective liaisons, and no longer needs this additional oversight. And very few change requests specific to just an NCPDP standard were ever entered into the DSMO process, as we already had a well- known process in place prior to HIPAA, to have changes made to the NCPDP standards.

So, in regard to the other entity or another entity being formed, I’ll reserve comments when we get to those recommendations.

TENNANT: It seems to me that we’re looking at two options, but there might be a third. So, is it disband or replace? I think I would argue the third option is to modify it. I think Rich, I would have concurred with your last statement where we need to look at the duties of the DSMO to see what we can sunset and what needs to continue. What strikes me is, there’s still a coordinating role and I think what we don’t want our standards developed in silos that might impact each other. And I would even argue that perhaps core should be included in that, because they have a direct impact on the X12 standards.

Where we need help is in these other areas, such as benchmarking and piloting and establishing R01 and business need. That can be done by a group like WEDI. But I don’t think we need to necessarily disband the DSMO. I don’t see that as being the barrier to moving standards forward. I think there’s plenty of other barriers. I don’t think that DSMO itself is causing significant delays in the development of standards.

SAWYER: Thank you, Rob. You made it easy.

It’s a ditto Rob.

TODD: So, while CORE agrees that there’s a need for coordination, we are concerned about the unintended consequences of adding another layer to the process to get standards and operating rules adopted. CORE has not been part of the DSMO and we feel as though that’s been one of the reasons we’ve been able to move more quickly to support business needs within the industry.

In terms of the need for coordination, we would actually ask what role NCVHS can play in that as a review body designated under Section 1104. And we would also comment on, given that there is an unintended consequence here for adding another layer that would add to the timeframe to get standards and rules adopted, to also consider whether we should move towards adopting processes in regulation versus adopting particular requirements, to enhance the speed. And there won’t be more comments that I have on that later.

COMBS-DYER: The CMS Center for Program Integrity supports the NCVHS’s recommendation to disband the DMSO. We support the streamlining of the process so that standards and operating rules, where needed, can be established more quickly and not sure whether that warrants terminating the MOU that established the DSMO or whether that means modifying the current regulations. I don’t know enough. But either way, CMS CPI stands ready to assist.

DARST: In response to WEDI’s Policy Advisory Group, I’m going to give you a multi answer. First, WEDI recommends that if the DSMO – Rob said modified, we said modernized – then a revised DSMO should be responsible for oversight and stewardship to improve the process of accepting new versions of the standards and operating rules in a more timely and consistent manner.

However, and I’m actually jumping to the next recommendation, if there is a new entity, then it should be a coordinating entity responsible for the effective intra- industry collaboration, outreach, evaluation, and cost benefit end reporting. As a number of people have suggested, WEDI, we certainly welcome the opportunity. We have been a leader in many of the major discussions in the industry with the implementations of ICD-10, health plan ID, NPI attachments, and we’ve worked with the different SDOs on many of those.

Regardless of the outcome of what the decision is, we need to ensure that there are no gaps created through any changes that would impact or hinder any forward movement of the standards and operating rules.

LESTINA: First of all, Rich, I really do appreciate that clarification of redefining, because to me, I interpret that very differently than as it is proposed. I think redefining and completely disbanding are very different and so our comments, of course, are based on the interpretation of that. And I would say that redefining might have provided further clarification, so I appreciate that.

I agree with Walter and a few others that also mentioned that another governing layer has potential, with unintended consequences, to continue this elongated process, so I’m not sure that’s the right – and I know I’m jumping to the other one, but unfortunately, I feel they are somewhat tied together. I think for us what isn’t clear is that, in the proposed recommendations I can’t discern exactly what would be different with this governing body than some of the organizations that are already out there and what they’re doing. It’s hard for me to say I can support or not support a recommendation when I’m not clearly knowledgeable on exactly what that organization would be doing and exactly what the differences are.

So, my proposal is, whether you just disband or not, isn’t yet ready a decision to be made, but we figure out and can outline exactly what that organization is going to do, so I have the information to make that decision that, yes, I see that difference. So, I definitely agree with expansion, the redefining, but still again, clarification of exactly what this new organization is going to do that’s different and how then, this organization is going to interact with a number of the organizations that are already out there participating.

SPECTER: I just wanted to add an element to what some have already said. We do see a need for this ongoing fostering of collaboration and support among and across the SDOs, which that could be through whatever entity it is that gets put in place for that. But this idea that we need to have something that can help us with that cross SDO work and especially as we’re considering changes in HIPAA standards and other ongoing standards development or interoperability developments that offer varying solutions for the industry. And again, one of these areas, attachments, is one where we’ve got standards coming out of different SDOs and there needs to be this coordination of how that is all going to work together.

And then there’s other industry initiatives that are going on looking at ways of moving that clinical information and so there needs to be some group that can sit outside of that and really look at what is being proposed or being developed and how can that all fit together. And then going back to Rob’s points, the idea of then looking at cost benefit and pilots, so an entity that could focus on those aspects.

HERD: I’m going to ditto a few other comments around the table. We’re not sure that we see what the strong need or benefit would be from creating a new industry governance entity or how that would contribute meaningfully to process improvements. In fact, I think it’s maybe just as likely to have the opposite effect of consuming industry attention and resources that could otherwise go into other process improvements or progress.

GINGRICH: We agree with the recommendation and I’ll just ditto Michael and Walter and Margaret and others.

BEATTY: Gary Beatty with X12. One point of clarification in the recommendation is, again, is it disband, is it replace or so forth. Because it almost takes a two-step process as Rich pointed out. And you did a very good summarization. I remember the day we actually created the DSMO, a long time ago, with Barbara Redding and a few other folks in a room in San Francisco. I agree with a lot of the other comments.

I think the DSMO has served its purpose. I think the industry has learned where to go to deal with how to request changes to their respective standards. But to really do what we’re talking about, there is really almost a two-step process because we have the regulatory process to go through to reverse the regulations that actually establish each DSMO organization. But then there’s also a second process where the DSMO which is actually formed by the memorandum of understanding and agreement between the six organizations that make up the DSMO, which did not include the Department of Health and Human Services in that. So, there’s really a two-step process to make that happen.

So many people have been talking about replacing what the DSMO did with this new group and I don’t know if that’s really the case because I think the DSMO has served its purpose and we’ve achieved a goal, and the industry has moved on. We’ve learned. So, the real question is, and we’ll get into that as we get into some of the other discussions, what would this new group be. What’s their purpose? How would we generate consensus? How would that group improve the process, not have any unintended consequences, and really clearly define how and what this organization would do for the industry?

KOCHER: We’re not necessarily opposed to disbanding the DSMO, but we need to understand what a new entity would bring to the table. Just putting a new entity in place because we think we have to have something, that doesn’t bring any new efficiencies to the process, doesn’t serve any of us. We were also very careful not to use the term governance. We don’t think that governance is the right approach. The standards organizations are already held to their governance process through ANSI, so we don’t want to duplicate things that are already occurring for them.

We do think there’s a benefit to enabling that coordination at the organization level versus the participant level, and we think it could help align if all the standards operating rules and everything was going through the same process. Right now, we do have two processes that are not 100 percent aligned with each other.

MIKKILI: So, less is more. And I agree that we do not want to add another layer. We have so many standard developing organizations to keep up with and we need to leverage what we have currently. Ditto what Gail just mentioned. We have an operating rule process which doesn’t go through DSMO. And a lot of voluntary adoption of operating rules in the industry. So, I agree that we do not want to build another process, just leverage what we have and keep it simple.

GOSS: What I’m hearing is that coordination is important, addressing the gaps that we’ve understood as being longstanding issues, testing, return on investment, broad-based education and enrollment of the industry as a whole, are things that seem worthwhile to take on in a maybe refreshed model, or maybe it’s the DSMO itself. But as we envision the history or the original purpose, that’s sort of been met but there’s an ongoing need that we still need to tackle. Am I hearing this correctly?

SUAREZ: I think what I heard, and probably everybody will have an opinion on what they heard, is generally, most people agree that the DSMO has achieved its functions and its goal. Now, the question is not about this recommendation, it’s about the next one, in many ways. And the answer to this question might depend on, what is the answer to the next question, for the next recommendation.

Some people said, well, this might make sense, but it depends on what we decide to do about replacing or not doing anything. So, I suggest we maybe go to the next if that’s okay.

LANDEN: As Alix summed it up, I heard pretty much the same thing. There’s a decision to be made about where we go next. So. Recommendation 4, here. Let me just read it quickly. HHS should enable the creation of an entity tasked with oversight and governance. And to Gail Kocher’s point, governance we’re using with a small g and the term that we’re kind of migrating to is stewardship because we’re not talking about a command and control process, but a coordination process.

So, oversight and stewardship of the standards development processes, including the evaluation, new HIPAA standards, and for sake of discussion, the operating rules are in there in the draft from the subcommittee on standards, and we’re saying then that HHS would provide financial or operational support of the new entity – that’s something that did not occur for the DSMO – to ensure its ability to conduct effective intra-industry collaboration, outreach, evaluation – which had been mentioned many times this morning – cost benefit analysis, and reporting.

Oversight criteria would take into account the ANSI essential requirements for any ANSI accredited organization. These would also provide consistency to governance of all standards and operating rules entities.

So, those are some of the things that the standards subcommittee is seeing as potential value of some sort of, let’s call it a replacement entity or DSMO 2.0, whether we want to do a clean break and create something new. Whether we want to sunset DSMO, not do anything new. We’ve heard opinions on that. So, the questions get down to, does the industry, as some have suggested, have each of the organizations developed and baked in their own processes now about the content, the business requirements and how those work into the standards development world?

Or is there something that must be continued from the DSMO process to provide this collaboration? And then there’s a third question. Has the nature of the industry evolved to something that there is additional value that we can get from some such organization that would help with the collaboration among all the expanded number of entities? And when we talk about terminology and vocabulary and some of the other NCVHS work, there’s a lot of players in this game that were not incorporated in HIPAA, either the covered entities or in the DSMO organizations. Is there additional value to be gained by bringing those entities to a new table to move the industry forward?

All this within the understanding of, the charge is efficiency and effectiveness to streamline things, not to create layers and layers of bureaucracy. One of the primary intents of this whole predictability thing is to simplify and streamline and move the industry from a time when a business need is identified to the time there is an effective solution available and legally able to be implemented by the people, by the business partners, who need those transactions and standards. Discussion open.

SUAREZ: Yes, so following up on my previous comment, our position is that first of all, the words oversight and governance are too strong. It should be replaced by coordination. It should be a coordinating entity, number one. Number two, that should not be embedded in any regulation. The DSMO was created through regulation and then through MOU and it created, through the regulation, a series of expectations and steps that needed to be followed. If we were to use the same approach, there is inevitably the reality that this will continue to, or even potentially expand, the bureaucratic process itself.

So, is against your own goal of simplifying.

So, incorporating this into some regulation, a new form of the same old, DSMO or 2.0 or whatever, into a regulatory process or creating an expectation that it has a very specific regulatory process function, is going to be countered. So, the industry has the ability to establish some ways of interconnecting and cross-coordinating through a process to your body, that can represent all the SDOs, for that matter. And it doesn’t have to be mandated, regulated, establishing some regulatory process. And the function of that coordinating body would be a coordination function not policing, evaluation of accreditation, oversight, governance, any of these expectations that could make this new organization, if it was needed, something that would add steps to this process for adopting standards.

So, our recommendation continues to be that, there should not be a formal creation of a new cross-SDO body organization to perform oversight and governance and evaluating accreditation and policing and all these functions through these processes. The industry should be asked to consider creating, on its own, that type of a cross-SDO organization, if it doesn’t exist already. If it exists, then look into expanding its functions or deciding.

I believe that we have seen maturity in all the standard development organizations throughout this 20-year process of evolution. I believe we have seen a lot more cross-SDO partnerships and collaborations. And I believe that we need to avoid, through creation of this type of formal, regulated type of processes, we should avoid that type of creation because that will stifle innovation and the ability to adopt newer standards through that process, that are simplified standards that are done in a more agile way.

There’s one point that I think is important to note. I understand that currently, NCVHS does not have potentially the expertise, and probably never had the expertise, and the resources internally to provide a formal evaluation as it has been the case in the adoption process. And that through the hearing process is where NCVHS gets its input about whether a new standard should be adopted or not. So, that function should continue to be done and performed that way and not really expect that this new – if there is a new creation of an organization like this – would fulfill that type of a function. So, bottom line, our recommendation is not to establish a new organization.

COUSSOULE: Just to weigh in a little bit here. I’m probably one of one of the least experienced people in the room with regards to this process, having not been around in the industry when it was changed. But one way I would challenge people to think about it, a little bit – I think Walter hit on some of these points – is if you assume it went away and nothing else took its place, what would the gaps be and where would the challenges be.

It’s a very different way to think about it. It’s easy to think about, how do I tweak what I have. And that’s the way most people think about the world. But it’s a very different way to say, assume it’s gone, what isn’t working or wouldn’t work or would be challenging that might need to be done. And I’m not saying that’s the right answer. I’m saying it’s a different way to think about it. I’d encourage you to kind of ante that up and say, what would be the problems if it went away that wouldn’t happen or would need to be addressed. And that will help get into a, which place do you start from. Do you start from where you’re at or do you start from zero?

WEIKER: NCPDP is opposed to any entity created which would have any oversight or governance of our ANSI accredited standards development processes. We are also opposed to the creation of any entity that could elongate the process and increase administrative costs for the implementation of the standard. NCPDP recently went through the DSMO process and brought to NCVHS our updated version of our Telecommunications Standard or batch in our subrogation that we wanted to have adopted under HIPAA to replace the existing named versions.

When I look at that, I think, well it wasn’t a bottleneck. The DSMO was not a bottleneck in this process. That’s not the bottleneck. Let’s all be clear about that. But it added time to a process that’s elongated, and I have several examples of the amount of time it can take to have something that is considered small in the industry to be adopted. So, what problem are we trying to solve? What is the value statement? The DSMO had a purpose when it was created. It was highly successful but what’s the value statement of a new DSMO, a redesigned DSMO, a new entity? What is the problem we are trying to solve? This doesn’t get us predictability.

You look at what happened when operating rules were put into regulation and CAQH CORE and NACHA did not have to go through the DSMO process. They come directly to NCVHS. You hold a hearing. People come and provide input and the committee makes a recommendation. So, if it goes away you still have that process where you say, we’re having a hearing and we’re going to talk about the next version of the NCPDP standard. You get the people to come and testify whether there is value or benefit to it. So, replacing it doesn’t solve anything unless somebody tells me, what is the problem we are really trying to solve here. And what’s the value prop of some new entity?

NARCISI: I agree with Margaret when she says the DSMO did not slow things down. In fact, if anything, it gave more of a coordination and education to it. But the time has passed now. We are in a new era. But I think the biggest bottleneck, like I mentioned previously, is the regulatory process. And with all due respect, if it’s just the NCVHS that we go to to talk about these things, you really don’t have all of the expertise, as Walter said.

So, there needs to be something that’s established where that expertise is. It’s not a new standards development organization, but some kind of a new entity. And that entity has got to have the authority to say, we are going to roll into this new version, or we’re going to start using an HL7 standard for this. And so, I really think there has to be that process in place. And it’s not going to slow down. If anything, what’s in place right now is really slowing it down. The standards that are even going to be considered for the next version of the HIPAA standards, they were built 10 years, so there’s something wrong with this process.

SPECTER: We really think that there should be some further research done, specifically around what this group will be doing and the responsibilities. There’s a list of different activities within the recommendation here, but I think we need a clearer understanding as to exactly what the intention is for this group to be doing.

What are those gaps? What are those problems that we’re trying to solve? And once we understand the work that we want this group to do, then we can identify which entities are best suited to do that work.

And even in doing that analysis, it would also be beneficial to just look at sort of a cost benefit analysis in general, about having this group in place, what are they doing, and really be able to understand what’s the return on investment, not necessarily dollars, but just time, effort, meaningfulness that we’re getting out of this if we’re going to be putting this new entity into place.

HEFLIN: I think we already have too much fragmentation in our industry. We have X12 being used by a lot of folks in this room. We have NMSA for ER, which basically has the same basic data. We have CDA. We have FHIR, HL7V2, HL7V3, secure email, even more. So, I actually would be opposed to this and think we should actually look at the other direction and looking at coalescing these standards rather than further fragmenting the industry.

I also point out that we do have an organization that’s tasked with national coordination of healthcare I.T. standards present here, and I would actually suggest we look to them rather than creating a new entity for this purpose, and either the ONC, considering being the target of this and supporting this initiative or through their TEFCA coordinating entity process. Perhaps roll into that to help bring together some of these other standards, including NEME and X12 and others that are basically conveying almost the exact same information in 10 different ways, which really hurts all of us and hurts all of our ability to adopt and move forward quickly.

TODD: I wanted to echo the comments from Walter and Margaret. We are very supportive of those comments. And one thing I just wanted to put as an example is, I think we recognize the need for coordination, but at the step where the DSMO or another entity would ensure coordination, is too late in the process. It needs to be incorporated earlier on, when standards and operating rules are being considered, not at the end of the process or all of all of the time that we have taken from people has been wasted. It needs to be earlier on. That’s why we encourage collaboration early on in the process with the SDOs and the work that CORE does.

The other thing that we would recommend is that when you’re evaluating ROI, that that should be earlier on in the process as well, not at the end of the process, so that you focus on the right things and addressing the needs that the industry actually has.

GOSS: I heard ditto on that one from Suzanne. I just want to clarify because I have cards kind of bopping up and down. I have Chris, Arthur, Joe and Janet, as being on the list who haven’t commented. With that said, Chris, you are up.

MUIR: Thank you. So, I’m going to approach this a little bit as a sister HHS agency that has some oversight responsibility in the clinical role. I’m also going to channel some of what I’ve been hearing from the HHS Administration. One of the things that they’ve been hammering home is, it’s not only reducing burden on providers, but it’s just reducing burden on the system. And so, I would caution us about creating a new entity until we it’s very clear what they’re going to do and they’re not going to place any kind of burden on the overall system. I know that wouldn’t be the intention but there might be an unintended consequence.

I think the goal, when you think of what the federal interest would be in doing something like what we’re contemplating, the goal is much more about ensuring that the data is exchanged in a consistent manner, so that the data can be received and used. I don’t think the interest is in the federal government or even the entity getting in the way of the standards development organization and how that actually happens. We have a lot of center development organizations that are working on the different pieces and I don’t see that we have a particular interest in getting directly into that.

I do think there is a lot of value though, having said all of that, in the evaluation of the standards, because at some point HHS has to recognize them. If I understand the process correctly. Also, I think we have an interest in the cost benefit analysis and being able to describe to the stakeholders of why they should adopt these standards. And also, in the measurement aspects, so we can measure the progress. And so that’s the perspective I bring to it.

ROOSA: Wanted to ditto, first of all, Margaret’s statements. I thought April had an important point that I want to emphasize, that any talk about coordination needs to happen much earlier in the process than after an organization has developed a standard and passed it on to another body who is determining whether or not this is consistent or is in any way conflicting with what another organization has done, because you have wasted a lot of time at the SDO level in doing that, if you don’t have an early coordination.

In reading through this, I didn’t really understand exactly what this entity was really trying to solve. And I’m hearing that from other folks, too. I would ask, what gaps are there – as somebody else did – if this just goes away? What are we left with and how would you address that? I think that approach is important.

And addressing also whether or not the DSMOs have the technical ability to look at what the SDOs have come up with, I do think the SDOs do have that technical ability. I don’t think that the extra layer would be necessary.

GOSS: Joe.

BELL: I agree with a lot of the comments, especially when we talk about what the role of this organization should be for this group. But I think there is a gap and if we want to take the time to identify what gaps we have in the current process, because I really think we have to relook at how things are being done because we’re obviously not achieving our desired results now.

When we talk about stewardship or oversight, it’s not necessarily commanding control but who’s taking a look at this process to see is it working correctly. Is it performing the way that we want it to perform? By no means are we going to come out of this meeting and say, we got it all right. So, what organization is going to be responsible to take a look at that and see, what did we get right, what needs to be adjusted, so we don’t have to have meetings like this every 10 years or 13 years to go over that process again.

Another gap is the fact of scheduling all of this. How many SDOs do we have? How many standards do we have? What if they all hit at the same time? We’re all saying, okay, you’ve got to get them out in a year. Can we deal with every standard new standard coming out every year and trying to implement them in the industry? So, who’s keeping track of the standards of what’s coming, what’s on the horizon, and where can we best schedule them. That’s an important part of the communications that we go through. Do we need an entity to be a resource, a shared resource for the SDOs? For example, for forums and some of the technical operations of the SDOs. Would it make sense to funnel that into a responsibility in an organization and have them be able to produce the best of breed operations of that?

Although not the role of the DSMO, these are some of the gaps that we currently have that need to be addressed when we go to realign the system.

LANDEN: Let me just respond to Joe, in saying, hold those thoughts because you’ve kind of anticipated two points down the road when we get into Recommendation 8, so we’ll get back to that. Thank you.

CAMPBELL: I guess what I have is more of a question. It sounds as though this is one of the more controversial recommendations that we’ve heard so far today. And I was kind of curious taking Nicholas’s question, in making this recommendation, what gaps did the subcommittee see that needed most addressed by a body like this?

GOSS: I believe that we saw the issue of strong collaboration across the SDOs, testing and verification of the standards to be recommended from an evaluation perspective, good industry outreach and education, doing the ROI work, and helping us understand the implementation and the benefits from an overall adoption perspective. Having been someone who was not there quite as early as Gary might have been, in the actual formation of the MOU, but came in very quickly thereafter and had the pleasure of sitting through the fast track effort, and spending a lot more time at the Chicago Hilton Airport Hotel than I wanted to, there have been some longstanding issues that need some funding and some designated authority to kind of pull it off, that overarches the industry, and that the DSMO has done a tremendous job, especially in the early years. But they weren’t given all the tools in the toolbox of what we see as the missing gaps now.

So, I’m really glad that we phrase things the way we did because we’re all starting to really give us some good input. But for me, when I look at the last sentence of the Recommendation 4, that’s what we’re trying to get at.

And so, I’m really curious from all of you whether you think those are truly issues, and if they aren’t, I kind of go back to what Nick said. Does it matter if it goes away? What problems remain?

WEIKER: I want to ditto April’s comments about the ROI, and the fact that they come here. I know when I was the former chair of X12 and we brought 50-10 forward to NCVHS, there were provider types that came and said, oh, we had this problem with this transaction. It requires us to put in an address and we practice out of our home and we counsel prisoners and we don’t want prisoners to know where we live. But it’s like, okay, where was that requirement when we were developing this standard. Nowhere. There was no change requested in DSMO. There was nothing brought forward to S12 or any other SDO or data content committee.

So, you’re going to have these things no matter what you do, what you form, what you create, how much you educate, how much you outreach, there’s going to be a pocket of somebody sitting there that won’t pay attention until it gets ready to say, you must now do this, before they open the book and start reading it.

So, when I look at the last sentence and it talks about the intra-industry collaboration, we do that today already. Now back when the DSMO was first formed, and if you go way back, it was going to be called the NUDC, the National Uniform Data Content committee before it even became DSMO. We do that collaboration today. Outreach, evaluation, cost benefit. I’m not sure, reporting’s pretty general, what type of reporting are we talking about. But from an NCPDP perspective, we do those things. We look at our changes and say, what’s the benefit of doing this. It will reduce the pharmacy having to call the payer to ask a question about the response, and they give us a direct phone number, and we know what help desk we’re calling.

We go through and say, what is the benefit of making this change. So, it may not actually give you a hard dollar. It may say, it may reduce call volume. Well, you can’t put a hard dollar on that, it depends on who you’re calling and where they’re at and a bunch of other things.

But again, we need to decide what’s the problem we’re trying to solve, lay it out. I think it’s time to lay it out and name names and do whatever it takes, so we can put the minds of all these people in this room to solving it.

COUSSOULE: A couple of interesting points in my head, Margaret, if I can take a chair prerogative and comment for just a second, two thoughts. One is, the idea of perfection is frankly just not possible. You could spend 30 years developing something and the day you turn it on, there’s a problem. You have to balance that off with, how much diligence do you have to do to be productive. There’s no magic to that, it’s just something that has to figure itself out. But I will almost always default to reducing friction in the process, regardless of what the process happens to be. And so, I’d ask people to think a little bit about this when we talk about the different points here that are even referenced at the end, not that the same organization or structure doesn’t necessarily have to solve all those problems, but how can we reduce friction in total to get back to what Chris’s point was. How do we reduce burden and burden? And I would argue, friction is burden whether you look at it or not from a day-to-day operation perspective. But if it’s friction that reduces pace of being able to accommodate a change, then it is in fact burden. So, I’d ask you to just also to think a little bit about that and how do we think of friction in this world, this ecosystem that we live in and whether there’s an opportunity reduce to reduce it.

MIKKILI: I think from my perspective, the challenge today is the next final rule that we all are waiting for from a very long time. So, there is a gap. Is it the response from the HHS? Are they taking a lot of time or we are not recommending them enough standards or operating rules? There has been lot of recommendations from NCVHS, so there are a lot of responses that we are waiting from HHS. I do see that there is a gap in the process. We shouldn’t be adding a layer to that. But here with this recommendation, the process that is working really well, which is the operating rules, we are trying to add another layer there, which would complicate the process more.

So again, I agree with everybody. It’s the gap. Where is the gap for the next final rule? Is it the delay from HHS or is it our process?

GOSS: Could you clarify? You’re talking about the attachments rule, perhaps?

MIKKILI: No, any next regulations.

Attachment, we are eagerly waiting for it, but we can’t really implement anything unless it’s compliant or regulated right.

GOSS: So, it’s more about just needing the federal hammer to do the upgrade.

MIKKILI: Yes. What should we do next?

Everybody looks for directions and if it’s more of a rule coming out, it’s easier for everyone to implement.

GOSS: Gary.

BEATTY: Gary from X12. Just to answer Nick’s questions, it kind of goes back to what I said earlier. Are we really replacing the DSMO or are we creating something that’s doing something totally different? The DSMO really performs two functions. One is, it was originally intended to be the coordinator to receive change requests. If that goes away there’s really no impact to the industry because the industry has learned to come to the SDOs to request those changes. So, there wouldn’t be an impact from that perspective.

The other major function is, as mentioned, to come back with recommendations for changes to the standards or new requirements. I’ve heard that the comments from a couple of folks saying that it’s not a bottleneck and so forth. But if it were to eliminate that process, that would actually take one step out of the adoption process and simplify the process by doing so. So, it would actually be of benefit to do that.

Now, are there other functions that another group could do? I would just say ditto to Margaret’s comments. I believe that those functions are currently supported by the SDOs and ORAEs.

GINGRICH: I agree with a lot of what’s been said here. We do, as a company. In particular, Margaret’s comments resonate. As far as an organization to define return on investment, I don’t get that. I think that, as the industry that comes together for say an SDO, for NCPDP, we do that. We have to see a value on what we bring forward. That should be part of the recommendation. Now, dissemination of that and communication of what that is, I think that’s important but not necessarily creating it for the industry. I think that can happen through pilots, the community efforts, and then also through the SDO.

TODD: I just wanted to add on a few comments to the ones I made prior about process. As I mentioned before, I think it is important to have collaboration and ROI happening earlier on. Many of the SDOs and operating role entities are doing those processes upfront. If there are issues with that and to assure coordination, there’s a role that NCVHS can play, as a review entity to specify these are the types of things that we want to see in the review that incorporate ROI, that incorporate collaboration, that if these are not included as part of what comes to us for review, that you won’t review it. You put some requirements around what needs to have happened before it gets to NCVHS.

ALSCHULER: Yes, multiple dittos. And also, that what I’m hearing in terms of identifying the gap and what problem is trying to be solved and looking at the proposed scope here, is that attachments are a real case in point. We’ve looked long and hard at how to define and justify the ROI for attachments from a provider perspective. Not necessarily from a peer perspective but from the people who also need to be part of that handshake. And there’s some data from CORE that’s at a very high level. But you can’t say there’s going to be so many billion savings nationally. You can’t take that to provider organizations because it doesn’t tell you anything about what their costs will be and the benefits down the line.

So, it’s a real case in point where there is a tremendous gap here in being able to roll this out to industry imminently, we hope, we think, maybe, and say, why, at a ground level with providers, what is your benefit going to be. So, there’s definitely a gap.

But I also agree that this work has to start so much earlier and that really resonates against the discussion this morning that there has to be a continual test and evaluation process during the standards development, so that it’s not something that gets tacked on at the end. So, I think there’s a consistency there. It’s nice to hear that Surescripts and the pharmacy industry has that in hand, I’m not sure, frankly. I look to others to suggest how best to foster that.

GINGRICH: One little quick thing to what Nick said about the friction. I’m not interested in another organization that doesn’t have some definition to it, but around not having friction, I prefer to look at the other way and it’s more about the lubrication of what exists and fostering what’s there and investing in the SDOs and the work that’s happening through organizations like DaVinci and Argonaut and other things like that, or lubricating.

SAWYER: A lot of people probably read 7 Habits of Highly Effective People. One of the things is, begin with the end in mind. So, if we’re looking to smaller, faster turnaround, if we’re looking to having more predictable processes getting these things out, we need to look at, what do we need to have in place to be able to accomplish that, too. So, I think we’re going to need something, whether it’s called the DSMO, or – we’re going to need that kind of process. But it’s going to have to turn things around quickly. It’s got to be able to accommodate taking these things in and making them happen. But we need to be looking at that end. And the end is more rapid turnaround of things that meet industry needs.

When we’re discussing this, DSMO, not DSMO, or some other entity, something has got to be in place to accommodate this. I think if we try to do this with each of the different standards SDOs out there, individually, without some kind of a quick turnaround, collaborating body, I propose that we do need to have something in place. But it’s got to be something that could work quickly.

LANDEN: Let’s have one more comment and then we’ll move to the next.

BANKS: I’ll just be quick. I think we definitely need further study. There are gaps. We need to identify those gaps, find out if there’s existing organizations that can take on those roles. What I heard here was funding, which when we come to provider outreach or stakeholder outreach funded, take a look at the metrics. ROI, I think would be a whole lot easier thing than asking our volunteer SDO organizations to come up with this language that needs to be in the right grade level in order to be understandable.

So, I think there are gaps and that we need to study it further because we don’t know what we don’t know and we’re looking at our existing process. And if we’re truly going to modernize this, what we’re seeing today is not going to be here in five years since we’re still looking 10 years with 70/30, I’m not going to hold my breath. But if we’re truly going to revolutionize this process, we should be seeing a whole different picture in five years. That’s why we’ve got to figure it out first. We can’t just create something to create it.

LANDEN: Very good discussion. Thank you.

Different viewpoints, some threads we have strong consensus on, others we’ve got some interesting differences of opinions. But again, as I pointed out in my opening remarks, they’re all contributing to an end goal which elevates the whole system force, and that’s one of the points of today’s meeting.

If we can go to the next slide, administratively, I don’t think there’s going to be much discussion on this. So, after this slide we’ll slide into our break before we pick up a next, probably more in-depth, discussion. But Recommendation 5, HHS should conduct appropriate rulemaking activities to give authority to a new governing body replacing the DSMO, to review and approve maintenance and modifications to adopted or proposed standards.

I think we’ve talked this through fairly well in the last two slides in the consensus. There’s a decision to be made, more information to be gleaned, before we make that decision about if there is a replacement for the DSMO, what should its charter and mission be. And depending on that charter and mission, who should be involved and how do we fund it, and how do we slot it in, that it adds value and doesn’t drag out the adoption process. So, with that let me open that to see if there’s anyone who would like to comment on this slide. If not, we will go to break.

SUAREZ: Just a quick comment on that. I think, again, there is creation of a new entity and it is regulatory process, HHS establishing rules. There is also the idea of, if there is a need for such an organization, which there is differing views on that, but let’s assume there is one need. Certainly, as Eric mentioned, there is already an organization that exists that links all those SDOs. The other alternative instead of going through this route is going through the voluntary industry establishment of that entity, or endorsement of the existing entity whatever the case. The way we see it, there is no need to force the creation of an industry organization through a regulatory process. So, I just wanted to offer that as another if, in your if sequence there.

BURCKHARDT: From DSMO perspective, the only thing to add, which has kind of been touched on already is, with this process, the current process under the DSMO could take up to 90 days unless one of the members had asked for an extension. So, is 90 days too long? From this one we have more questions. So, we want to make sure that whatever this new thing is, if it does occur, we don’t want to impact the standards development. And so, the questions we have to ask ourselves, does this process need to be proactive, which we’ve already touched on. Do we need to be more engaged in the development process? Again, it goes back to previous comments. How do we streamline the process and integrate the standards into this process? And so, we do have liaisons as SDOs and we have the data content committees and all the different data maintenance. I know they’re at HL7, they’re at X12. Do we somehow need to do more of a formal process in getting them more involved in having a voice at the table at that time, and having it weighted?

We talked about before, when Jean, you spoke to when the ADA, you have one voice, but that voice actually represents a large community. And I know that – for a minute I’m going to wear my X12 hat on – as TGB cochair, one of the things I’m always after the coachers is to remember is that it’s one voice but look at what that voice represents. You always want to make sure if you have a provider and payers that are not in sync to each other, you have a problem and it’s not majority rules. You really need to take a look at the whole thing. If this process continues, those are some of the things that I think we really need to think about.

MUIR: Yeah, as being a federal person and being very pragmatic, the answer to this question, if you do decide to go ahead and create a new entity, this will be determined by a group of HHS lawyers and not by any other committee. Just being very pragmatic about it.

(Laughter)

(Off mic response)

GOSS: We would like to propose it’s time for a break.

(Break)

GOSS: We’re going to go ahead and get started. Here for the afternoon we’ve got the last major push in Outcome Goal 2. So, I’m going to turn it back over to Rich to facilitate the introduction of the next recommendation.

LANDEN: Thank you Alix. We’ve kind of pretty much wrapped up our discussion on the DSMO. Thank you very much. A lot of very intriguing thoughts, suggestions, opinions, and you’ve made our subcommittee’s job both harder and easier. So, thank you very much.

Moving on to Slide 26 here, Recommendation 8. We get back into the main theme of predictability and the DSMO was one discussion. Another sticking point in the process of why it’s taken the industry so long to move from one version to an updated version even when there’s a compelling business case that we need to move, is at the HHS end of the spectrum, once NCVHS comes to a decision and makes a recommendation to the Secretary of HHS – and again, HHS gets it from the DSMO, DSMO gets it from it the SDOs and so there’s a whole chain there. So, when NCVHS pushes its recommendation to the Secretary, under the rules of the Federal Administrative Procedures Act, there’s a whole process that the Department of Health and Human Services needs to go through. And in the history of HIPAA, that has taken a very long time and there is no certain end date for that process.

So, Recommendation 8 reads, “HHS should publish regulations within one year of a recommendation being received and accepted by the Secretary for a new or updated standard or operating rule, in accordance with what is permitted in §1174 of the Act.

So we’d like to get your opinions on that.

Obviously, the caveat is that NCVHS can only recommend to the Secretary. As I pointed out, the Secretary and NHHS have a whole series of obligations under the Administrative Procedure Act which includes review of NPRMs and final rules by other impacted federal agency, clearance by the Office of Management and Budget, and review by tons and tons of lawyers.

With that, let me open it up to discussion. What is your reaction to the Recommendation 8 about recommending to the Secretary that there be a one-year target date between the time the Secretary receives a recommendation from us and we have a final rule?

GOSS: There are a lot of cards that went up on that one.

TENNANT: As well-meaning as this recommendation is, it has really no basis in reality. There is nothing that we can do to impact the internal decision making of CMS. This is done at a political level. It’s done at a tactical level. I would urge that the recommendation be more along the lines of, once the recommendation from NCVHS is received by the Secretary, we urge expedited review and release. But putting a timeframe on, I think would require a legislative mandate. And even at that, as we’ve seen with HIPAA and the ACA, it’s more a suggestion to CMS than it is a mandate. So, again I would urge a tweaking of the language.

HINES: Let me just say that the committee is at the liberty of making suggestions and I think that’s what this is. Obviously, the committee can’t make regulation policies, much less law, so I think that was that was the spirit in which it was intended to be taken.

WEIKER: Much like Rob, when I saw this, I said, well that would be a breath of fresh air. Having experiences with something right now that’s been six years in the process of changing the field from not used to situational and were ongoing for years now in regard to the electronic prior authorizations being named. So, when I read this, I’m like, yes, they must – somebody needs to put the word must, not should, because that recommendation says, should – must needs to be that the recommendation.

They must implement these things in a timely fashion. And maybe one year is not applicable, but to have something go on for 4 years or 10 years or 21 years, is ridiculous.

And I understand there’s processes and regulations and acts and legislation, but we can get out changes to Medicare Part D on a yearly basis, that updates how things are implemented. They can name standards without going through the process that currently has to be undergone with HIPAA. You look at ACO, Meaningful Use, the changes that can be made there, and how quickly some of that happens, and maybe it’s not quickly, but it appears to be a lot quicker. NCVHS makes a recommendation and it just goes into a black hole. No updates. We can see in the semi- annual regulatory agenda where they look like they’re going to name things, but they’re not held accountable.

So, when you look at predictability and moving these things predictably through that process this is the bottleneck. This is to me and NCPDP, this is the problem. We can produce standards on a quarterly basis if need be, but we sure can’t get them adopted on a quarterly basis, a yearly basis, or every four years or every 10 years.

MUIR: Now I’m just going to sound redundant, but my reaction was one year like supersonic fast. It takes us 18 months if we hit every single deadline that we have. I just can’t see how it’s possible to be done within a year. My other reaction to that though as well is, we’re right now trying to think through, how do we incorporate standards and stuff without actually having them having them written into the rule, so that we have the flexibility to update things without rewriting the rule every time. I think that would be a worthwhile conversation for us and our attorneys to have with you all and thinking about how we do something like that.

ROOSA: I find myself again echoing Margaret. It’s important that to bring predictability to this process you have to have something that says that, this is going to happen in a given period of time. It is not predictable to say that NCVHS will recommend to the Secretary a change that the Secretary can then take 14 years to implement. And that’s not predictable. Chris is indicating that one year is too fast. It’s interesting that later in this discussion we’ll be talking about standards not keeping pace with the evolution of technology. And if one year is too fast, two years this is not going to be keeping pace. How to reconcile those things, I’m not sure, despite the fact that Danny asked me if I had all the answers figured out earlier.

I think it’s important that there is, in our suggestions and your suggestions to HHS, that in fact there is a time limit for their response. And also, if I’m going to wordsmith this a little bit since Margaret changed the word should to must, I’d like to change the word and to if, so that we don’t really extend that period of time just waiting on acceptance which could just simply be expanded for two or three years.

GOSS: So, I’m kind of curious. You’re saying one year’s too fast. Two years is too slow. People should maybe think about the next round of commenting about what do you think the sweet spot is, while we defer to Danny’s comments.

SAWYER: My comment ended up being pretty much a ditto, ditto. I agree with the must. Should is too soft. My comments or our comments that we submitted as well, something’s got to be institutionalized and the institutionalization of that is really the must. It can’t be just a shall or maybe or a should. Otherwise, it’s a ditto. Thank you.

COUSSOULE: One thing I would like to add in, and I want to piggyback on top of what Chris was talking about just a few minutes ago, and that is there a way for us to creatively structure the process by which the federal government does not need to issue rules to allow this process to move through faster. And again, I’m not trying to skirt anything, but I think we need to think about what the right framework is to allow pace to happen at an industry acceptable and reasonable pace while still providing the level of oversight and governance and authority that you need from the federal regulatory environment. So, I think that’s something to think about for some of you who know a lot more about this. I’d love to hear some thoughts on that.

KNAPP: We were just talking internally about similar to the complaint process if it would be helpful if HHS could provide some transparency on the process of how things go through and get approved. I think a year would be wonderful. As some people have mentioned, sometimes recommendations from NCVHS go into a black hole and that might not be the case. They might be under scrutiny with lawyers, who knows. But maybe if there was some way that we could get some kind of transparency on where it is in the process, it might better help understand when it could be coming out, if it’s coming out or also hold agents accountable to having it in a process and we kind of get a status update on that.

COMBS-DYER: CPI really believes in innovation and would love to see HHS develop sort of a rapid adoption for new standards. We’d like to really see the process simplified maybe having – and I think this might get into Recommendation 11 that we’re going to be discussing tomorrow – the adoption of floor standards but then allowing for trial use of emerging standards, either by expanding or clarifying what the exception process is. I’m just learning that and a little bit befuddled by that whole process. Maybe this gets into the transparency of how all this stuff works.

I’m just sort of brainstorming. I wonder if perhaps this language could be changed. Nick, this might get to your point, either eliminating the need to have regulation altogether. I love that. I’m on several reg reduction committees at CMS and always in favor of eliminating regulations wherever possible. I also know, at least in the parts of CMS that I work in, on the Medicare side, there oftentimes are annual rules. Think about that annual physician fee schedule that comes out. Everybody knows what the cycle is, when the NPRM is coming out, when the final rule is coming out. Maybe it would be possible to do an annual. That’s not to necessarily say that the particular provision that you want and love is going to make it in within one year. It might take two cycles to get there but at least there would be a little bit more predictability. If there was an annual standards rule that came out

SUAREZ: We’ve been putting a lot of thought about all these points and I think when one thinks about the process, one can divide things into three major areas: the standard development and maintenance process, the evaluation consideration and recommendation about adopting a standard, and then the regulatory process. What we propose in our written comments is a brand-new paradigm that really consider the three elements as places where a lot of opportunities for improvement in the process itself can be gained.

And on the regulatory side, just to focus on this point, we are recommending that instead of having regulations that specify to the granular level where we are specifying at this point, which is the version, the date in which was published and everything else in the details of the regulation, we’re recommending that actually the regulations be much more broad in terms of what it enunciates and that become a floor rather than a ceiling in terms of the standards that has been adopted. In other words, yes, the minimum standard that everybody should use is this one, but people should be able to use newer standards and be more dynamic to allow people to do that.

There’s been reference to a number of projects like Argonaut or DaVinci or other projects in which a new standards and new technology are being explored for precisely the type of transactions where we’re having the biggest concern and biggest challenges: prior authorization, illegibility, and other things. And in reality, there is a certain degree of limitation, if not complete limitation in terms of the ability to use those newer technologies such as open APIs and newer standards such as FHIR to conduct the named transactions in HIPAA. So, if I were to do through an API and FHIR a prior auth today, I wouldn’t be able to because the rule says you have to use 5010 and 278 or you have to use a portal through a directed entry.

So, what we are recommending is a complete, new paradigm in terms of regulatory development in which instead of naming the specific standard and then having to update that through a regulatory process that we know how long it takes, establishing broader expectations if you will, not naming specifics, and serve as a floor permitting the use of newer standards.

LANDEN: Walter, let me ask for a little bit of further explanation, if I may. If we set a floor standard and the newer standard becomes available, I hear you suggesting that newer standard could be put into voluntary use without new rule making. Indeed, OMC and its rules, when it comes out with its annual updates about EHR versions, does allow industry to move earlier to the newer update. The difference in the industries though is in in the traditional EDI – and this goes back, much like our DSMO discussion, to the protections built into the administrative simplification legislation that protected smaller parties from having to modify their systems at the behest of an unequal trading partner. The typical discussion is you got a small provider and large insurance company. Large insurance company says, if you want your claim paid you have to move to the new version. So, there’s language in the original HIPAA to prevent that.

Your suggestion is implying that those kinds of protections are no longer necessary. Can you talk a little bit more to that and what’s to prevent the big guy beating the little guy over the head?

SUAREZ: No, absolutely not. I don’t think the suggestion is intending to eliminate those protections. In fact, the creation of a base standard or floor standard allows exactly for that, for entities to say, well, I’m doing the basic standard. The other ones you can voluntarily adopt. Sure, there could be attempts by virtue of the size of an organization to force entities to move to a newer standard perhaps. But there is then, going back to some of the earlier recommendations on enforcement, there should be a mechanism in which entities will be able to say, wait, I’m being forced to move to these standard but I’m not ready and I’m still using this base standard as named. So, I should be able to continue doing that without being forced or penalized by not being paid the claims.

So, this in no way eliminates that protection. In fact, what it makes it is more an enforcement opportunity for protecting those organizations that are not ready to move to the new standard. But still at the same time allowing the newer developments, both in technology and standards, to be able to be used early on, to be able to be used legally. So, I’m not in any way suggesting that there should be an elimination of those protections.

NARCISI: So, the ADA believes that the NCVHS should make a recommendation to HHS that HHS gives the authority to this new thing that we talked about previously, entity if we want to say that name, in that they would have the authority for the release and dissemination and implementation dates as well as also with education of the new standards and operating rules without going through the regulatory process. It would point to that group.

GNAGY: Just a quick comment on the protections that you had talked about and I’ll take an opposite perspective from my own, from the provider standpoint. Am I supposed to accept all of the secondary potential standards that are out there? For example, you were talking about the big guy beating the little guy over the head. In this case the provider would have to basically go around and accept them all because the little guys are going to say, hey, I can only do this one. So, there’s a little back and forth there on that in terms of the protection if you open it up to say, you can use any secondary standard. Whereas, if you have something built into your system that allows those people to work and to extend that standard, your floor – which I concur on the floor concept – you allow them to build within a structure, not say, okay, here’s the floor and you can use anything out there. What list of standards – because I can come and say, well, we have our own standard which we do. You should adhere to mine. But I do like the floor concept a lot.

There are 600,000 providers and vendors also.

HEFLIN: Largely, I want to ditto Jean and Walter’s comments with a further elaboration of standards. Regulations are not intended to be nimble. They must take time to go through the process. They are designed to be a blunt instrument. However, innovation requires nimble behavior. I don’t think anybody in this room that I heard expressed the opinion they feel it’s viable for HHS to issue a new regulation within one year from the point of a clear ask is made of them. And yet innovation clearly requires that we have at least an annual update cycle.

So, in summary we’re asking the impossible out of HHS. This cannot be done. The system is broken as is and if we don’t acknowledge that we’re not going to fix it. So, I think a solution is, indeed as Walter and Jean said, that NCVHS should recommend that there is a broad public/private partnership with broad industry stakeholder representation, agencies, academia, standards bodies, and so on, that actually has been empowered by HHS to actually act as a convening body to actually create that on an annual basis.

ALSCHULER: Dittoing some of the thoughts here, but I probably know less about the regulatory process than most people in here, so I can ask really dumb questions. One is, what would help expedite that process?

For example, what data can be developed during the standards development process when we have this agile, continual test and implementation and ROI examination going on? What data can be brought to the table along with a recommendation that would make it easier to move through that process?

And another thought about speeding it up – because I quite agree that annual is probably the longest that we could tolerate and still maintain respect for innovation and industry needs – is what kind of collaboration can occur such that HHS or CMS or any entity involved has an assurance way before the recommendation that its requirements are considered. There are models of this within HHS. We work very closely with the National Healthcare Safety Network and CDC and we help them bring things through the standards process. Once it has gone through the standards process, because it worked with their requirements from the get-go, they don’t have to look at it and say, can we accept it, it’s their requirements. So, there’s no acceptance process there. So, there is some very good models for how government can actually approach the standards process, not as a foreign body but as an enabler for taking its requirements and putting them into a technical framework.

In terms of allowing the development of new standards, it’s allowed, not required. And we also have some very good models of how allowing use of a new standard can explode the pace of adoption. We started a pilot under ONC for submission of electronic pharmacy care plans with two vendors, with the expectation they would send it in using a CDA version. In the process, we said, well, let’s develop FHIR concurrently. By the end of 18 months we had 22 vendors implementing that. And the receiving body, in the process said, you know what, we were expecting we would accept the CDA and do transforms under FHIR. But you know what, we’re going to build up our infrastructure natively in FHIR and we can still take the CDA because we know they’re comparable and do a transfer.

So, it allowed those with the prior investment in CA to leverage their investment and it allowed those who didn’t have that prior investment to use the more modern, easier to adopt standards. So, this model can work really well.

TODD: So, the comments that CORE had submitted are similar in line to what Chris has mentioned and what Walter has mentioned as well, in that the timeline for new and updated standards should really align with where there’s value and that HHS should take a broad interpretation of the flexibility that exists within existing statutory language to not specify specific requirements and regulation but to specify a process for which standards and operating rules would be updated. In particular, they could specify the most recent standard and a timeframe with which that would occur or a recommendation on adoption following NCVHS recommendations.

And in terms of an annual notice, how the annual notice could be used is by HHS using that as an education and outreach tool to be able to communicate to the industry what is the most updated particular standard in an area and what the timeframe is for adoption.

GOSS: Thank you for those comments. I think it’s important to note that this stage is after the SDO has already done all their process, the DSMO and NCVHS, so it should be fairly socialized to be able to be advanced to the next stage. Interesting play on how to use that year.

Mark.

(Off mic response)

GOSS: Okay. Ditto, ditto, ditto.

HERD: A couple of comments about some things that I’ve been hearing. One is specific to the recommendation that’s on the board. Personally, I have no idea what the right timeframe to put in that. I would just encourage the subcommittee that if you feel strongly about making such a recommendation that it’s a pain point that you do so.

The second is around the idea of delegating authority to standards groups or operating rule entities so that their work doesn’t have to go through the regulatory process and approval. And I would strongly encourage this subcommittee in this industry to pursue that type of model. That’s our model for financial services. Our rule making is 100 percent private sector. When we vote as an industry and move forward on something, we move. We don’t have to send it to anybody for approval. And we move $50 trillion a year on that basis. So, I think there is a possibility of coming up with some framework to delegate authority to entities that they could have an industry approval process and when you approve it, you approve it. It’s done. So, I would encourage you to pursue that as well.

I know that this is kind of off topic, but I heard Walter’s comment about open APIs and that is also an area that NACHA is pursuing in financial services. We formed a subsidiary group just this year to develop standards for open APIs for data exchange among financial institutions and financial institutions with their customers. When I listen, this is all about data exchange between entities, I think APIs – it is hot topic in financial services right now and it seems like it would be applicable here as well.

GOSS: We are going to go to Martin next, then Minil, then Laurie Darst, Melanie, Arthur, Janet and Joe.

WILKBANKS: First off, I want to ditto the comment that, greater transparency as to where something is within HHS would probably help a lot, so it’s not a black hole, so we know exactly where it is. Is it moving forward, or has it stopped? With like HPIT, I think it was well known that we weren’t going to do it long before it actually formally got out, that would have been better.

For the question about regulatory change, we should incorporate into that processing acknowledgment that not all the changes to standards are the same. With my X12 hat on, having worked with the RFI Committee, we acknowledge that sometimes we look at it and say, well, it would really be nice if we could just change the wording a little so it’s more clear. Not changing the intent or not even changing how it should have been implemented, just an acknowledgment of, we could have phrased that in allowing the SDOs to do that kind of work outside of this regulatory release process, would be a big help for our industry.

The last point, right now, though especially 7030, I think we’ve gotten ourselves into a bit of a box. We are so long between the releases, by the time we get there, there’s so much even after we go through this process we need to allow time to implement, it’s going to be two years plus before we can do another one.

At some point we need to have acknowledge that moving forward, we’re not going to do this. We’re not going to let that technical backlog get so big that any implementation is going to take the industry a long amount of time to do. We need to get the discipline of keeping those packages small, so they go out.

MIKKILI: I think putting a timeframe from the time the recommendation is accepted until the rule is out is very important. I do not know if it is one year or two years or is subjective based on the requirement, but it helps us plan effectively. And I think to add, would be a regular communication on the status of where HHS is on that rule making would really help the industry.

DARST: From a WEDI perspective, we are dittoing what Rob had indicated earlier, not putting a one- year timeframe on but expediting, using that terminology.

Since we’ve kind of delved a little bit into Recommendation 11 and 12 about the floor and voluntary adoption, I just wanted to make a couple comments. I share the concern you mentioned, Rich, or WEDI does, as far as needing to have voluntary adoption. It needs to be mutually agreed upon voluntary adoption. This was a lot of discussion that we did have at our WEDI policy advisory group, that one entity should not force another entity into doing beyond the floor or doing the new innovations. So, we would really want to have some really clear language of what would be allowed and what would not be allowed.

One other comment that was made was, the impact if there are multiple payers in the loop having to do something one way for one payer for a provider and another way for another payer or even the crossovers, that type of thing. There is some huge impact. We have to work this out but generally we’re in support of innovation, but we have some things to work out.

JAFFE: I think there’s some key elements to this that were highlighted by Walter and Liora. I’d like to reflect on them. I think there are opportunities for collaboration, whether between the standards development organization and the public or private sector, that are critical that they begin in the development process not after the standard is being implemented. I think it’s critical that we write the implementation guides as transparently and as usably as we write the definitions within the standards development.

Trying to set a timeframe or define the standards development process is at best a trial by fire. One of the key elements to this is reflected in the critical development of 802.11, which we warmly refer to as Wi-Fi 802.11 has gone through all of these iterations broadly adopted in the industry, billions of dollars in investment and growth that we all take advantage of, and you know what, it’s never been a formal standard. It’s never gone through a ballot process. It just happens internally and because the marketplace adopts it, we use it. They have tools to assure conformance with the latest Wi-Fi standards, but no government agency regulates it. I think we can look to the successful adoption of some technologies and reflect on how we can encourage the broad use of innovative standards and still protect the needs of the smaller entities that aren’t financially or strategically ready for their adoption.

COMBS-DYER: I’ll ditto Chuck. I really think it’s important for SDOs to work with multi-payer public and private partners at the development stage. And I love the analogy of looking at how it works with Wi-Fi. No government stepping in and saying, this is the way it will be. It just is. I love that. Thank you Chuck.

ROOSA: Going back to what Walter sort of opened the conversation with, I think that he was referring to a system – and correct me if I’m wrong – that with establishing a floor – I know that we’ll get to this later in this process – but by establishing a floor of transmission standards, what we’re able to do is to simply say, if you are going to be a trading partner/provider, it doesn’t matter, in this process you must conform to this standard. You can use anything else that you want, and you can convince any other of your partners to work with you and exchange information with you with any other standard that you want to apply but you know walking in the door that if I don’t want to do that I can use whatever the current operating standard is and it will be something that will function.

Also, in terms of what Chuck said about Wi-Fi, I had mentioned earlier that I’m concerned that the incentives are misaligned in the healthcare industry. There are strong incentives for Wi-Fi to be consistent across the board. It only goes bad if that’s not true. But in the case of standards for data interchange, like for instance for claims admission, there is some incentive for that not to work, particularly in the small payer world. So, that I think should be a pointed discussion as we move through here. Otherwise, I think it will require some sort of government regulation.

CAMPBELL: I’ll preface this by saying, I don’t necessarily have a recommendation coming out of what’s going through my head right now. But speaking as a technology provider, we recently moved to a cycle of quarterly updates to our software and that was in order to bring needed enhancements to groups that were using our software more quickly. We used to be on a longer cycle. Probably the downside to that has been that as regulations change that means that now we need to, when a new regulation comes out and is required, we would need to patch that back to the versions that are supported. We went with a flow of something like three years, which is 12 different patches that we’re creating. That’s not just for these types of standards, but for the standards related to Meaningful Use to home health to long term care. It’s a very standards intense world.

And then even as we do that, there then is the process of organizations needing to take those updates. And sometimes it’s taking a small patch, but if they move out of that window then they have to do a fuller upgrade which can take more time on their part as well. And I guess my purpose in saying this is that, as Eric said, there’s some reason why standards kind of take time. And I think that if we move the floor at a gradual pace, I think that that actually helps. There’s a little bit more efficiencies in saving up a number of changes and then doing it once, versus doing multiple changes more frequently. There’s kind of a sunk cost that goes into those changes. And so, as I was thinking, perhaps that is one of the roles of the oversight body that you’re envisioning is to think through the timing and the impact to the industry as to when that floor moves

BELL: Definitely would like to ditto that last comment as far as figuring out the implementation impacts of this whole process. Co-operative Exchange definitely felt like when they saw these statements that they should say must, not should. And I think that’s the parent in us all. Our kids should obey. But I want to play the devil’s advocate here a little bit which is an unusual role for me, because we have to be very careful about the legislation process, vetting out information as, well, this should be finalized and just should be adopted before it actually is, because some people could be using that as an indicator of, yes, I should go forward with this. and there could be a severe impact in, are we forcing ourselves not to come up with the correct answer. We’re coming up with the mandatory answer.

I think that’s the same thing that should be applied across all the defined timelines, that we shouldn’t put in a structure that mandates a certain time period. If something goes wrong, if it’s the wrong decision, we shouldn’t just say, well, we had to, by statute, put one out in a year. We should put out the right ones first and then figure out how quickly can we do that.

GOSS: It’s hard to have one-size-fits-all all the time.

LESTINA: Yes, thank you. I just wanted to touch on Martin’s comment that he made a little while ago about, not all changes are the same. I think that is actually an important distinction as we are evaluating this recommendation. I think one of the things we should be considering is a way to distinguish changes from being perhaps like substantive versus non-substantive and being able to move the non-substantive ones through a more modified process, so that those can move through it faster. And then, take the ones that require further evaluation through something that really looks at that cost benefit analysis that is the right thing we should be doing but without holding up some of the other changes that need to occur.

BEATTY: As Walter pointed out, there’s really three processors or phases in this effort. We have the development process, we have the adoption process, and this regulatory process, which this item is trying to address.

This is the challenge of the three processes, kind of the tale of the whole process. I appreciate, Martin, your comment too, about putting 7030 in a box. Within X12 we have a process of maintaining our standards with an annual publication process with three opportunities to introduce changes to those standards throughout the year.

X12 is now moving to our maintenance process for all of our work products to follow that same process, so that we’re going to have three opportunities for the public to submit requests to changes to any of our X12 work products, including the implementation guides. To have three votes throughout the year and then one annual publication of all of our work products, so that we’re going to take ourselves out of that box and having that long delay between the versions of the implementation guides that are adopted to move to an annual process, which they can fit into whatever process we can get to go through for an adoption process as well as a regulatory process.

GOSS: So, Gary, is that in place today or when will that be effective?

BEATTY: It’s a process we’re currently working on right now. We’re going to start with our static technical reports, starting in 2019 and then as the 7030 Tier Threes are approved, we’ll move those into that maintenance process.

GOSS: Rob.

TENNANT: I appreciated hearing Chuck’s analogy of Wi-Fi and Mike’s discussion of how the financial industry was able to move ahead without federally mandated standards. But as a great philosopher once said, “Healthcare is complicated.”

(Laughter)

When you think about standards – I’ll use two examples. We did have a mandated standard for the healthcare claim, which is a relatively simple process. Yet we were able to create thousands of variations of that one standard through the use of companion guides, forcing providers to go through clearing houses. So, then we have a situation – and I’ll bring up the 275 again. That standard has been around for more than a decade. And if you talk with my friend Laurie Darst, you’ll find out that it’s in production with a small number of payers and providers, but it has not been adopted widely in the industry.

As much as I wish that we could just anoint a standard through SDOs and the industry would adopt it, unfortunately that’s not the case. We are an industry that requires the government to issue a mandate, I think mainly because there’s so many moving parts. We’ve got vendors on the provider side, on the payers’ side. We’ve got clearing houses. We’ve got payers and providers. Everybody needs to be on the same page. And if there’s no standard that is agreed upon by the industry and forced upon us then we’re not likely to move ahead.

At the same time, I’m all in favor of innovation but we’ve got to be careful. And somebody mentioned it earlier, we don’t want a situation where providers are forced, through contracts, to support multiple standards. I think that’s going to be harmful to the industry. So, I think we’ll get into it more tomorrow, in regards to some solutions. But I just wanted to voice that. Thanks.

GOSS: Margaret, you are up.

WEIKER: In regard to the comments about adopting standards, fear of regulation; long before HIPAA, NCPDP had standards developed by the industry that were widely adopted and used in the industry, long before HIPAA came about. So, when the comments were made about, well, healthcare can’t do this, pharmacy did do it. So, it can be done.

And I also know that in my former employer, we would implement standards. We would look and say, okay, this is the business function that we want to do. Is there a standard available? If there was, we would look at it and go, oh, well it’s going to require us to do this or that.

So, we would look to go, well, what does that take. What’s that SDO or whoever owned the standard, how do I modify that. Or if it was like night and day requirements wise, we’d be like, okay, well we’ll do it this way but maybe you know once we flush it out, maybe we’ll take it forward and have it adopted via a standards organization.

And actually, I think HIPAA has stopped a lot of that, where it’s like, we must have this government mandate in order to do anything and we’re not going code our systems and move forward until that final rule comes out because between the NPRM and the final there could be changes. So, we’re not going to do anything until we see that final rule. So, I think HIPAA has stopped some of the innovation in the industry.

GNAGY: I like the concept Rob was talking about, especially in that you don’t want providers – and what that really means is the providers’ software vendor – to have to conform to multiple secondary standards, extra standards if we establish that floor. And I agree because, like we’re saying, the big guy beating the little guy, well, the reverse is true as well, because now anybody can say anything on that.

However, the one thing that can affect that as well are the tools that we’re using. If the tools we’re using are static and they’re not able to flow with technology, they’re not able to merge, they’re not organic, they’re static, and we’re now establishing another static set of time where these additional static tools come out, again, I think we’re going to find ourselves well behind the curve.

GOSS: Danny.

SAWYER: Following up on Rob and Margaret too, in terms of actually having a final rule. So, within the Department of Defense we do what’s called the POM it’s the Program Objective Memorandum, where we do five-year budgets. Currently, I can’t put anything into a budget unless I have a final rule. I know, or I anticipate 7030 is going to hit between ’21 and ’25, that we’re going to have to have money to do that. But I can’t even put it in the budget. So, any time a final rule hits, it’s year of execution. Basically, you have to look for unfunded requirement money. I’ve got to look for money that was not budgeted for, to be able to execute these.

LANDEN: Let me follow up with a question on that. Assuming we did succeed, NCVHS, and the industry succeeds in establishing predictability and you knew for certain that a rule would come out in two years, would you be able to budget for it even though you wouldn’t know the specifics about what the content would be?

SAWYER: That’s one of the things that we were looking forward to, yes, is if we know something is coming out every one to two years. Because right now we’re starting to work on POM ’21, so we’re looking at ’21 through ’25. So, if I knew one to two years we would have a new rule coming out consistently, then yes, I can get that into these advanced budgets.

GASH: I would like to echo Rob’s comments from the provider regarding the variation that could be introduced, which could layer on cost for the providers in managing these transactions. A lot of the reason why we don’t adopt certain types of transactions is because we have to deal with so many different payers and they interpret the rules differently. And you just can’t hire enough people to remember, I have to do it this way for this payer and this way for this payer and this way for this payer. So, like everyone else, standardization and lack of variation drives efficiency. We’re trying to do the same thing, trying to keep our costs down manage the cost.

As I look at some of these related recommendations, I think it’s great to introduce the opportunity for using new technology, new capabilities, and developing new standards, testing them, and working through that and having this notion of a floor for the minimum operating standards. But I would also suggest an unintended consequence is that you end up with more variation, and at some point, you need to expire a certain level of standard and push the industry to whatever has been developed that is proven value.

And I would hope that as business professionals, we would be analyzing the value proposition of using new technology. And if there is value, you will see adoption. So hopefully, if you have that capability to leverage new technology and you have the ability to introduce it without having to go through some regulation process, you could allow the industry to advance and adopt and really see those efficiencies that we’re overall trying to achieve.

BANKS: Just two quick questions. One is, we’re assuming HHS is always going to receive and accept. And if that’s the case, then why are we even sending it to HHS? So, we may want to amend it that they should publish regulations or clarify why it will not be published within a year.

And then, since everybody’s jumping on the floor conversation, obviously I want to jump on it as well. We’re already working at the floor. Right now, 5010 is our floor. And when we have a client need and we can’t use 5010, then we use APIs, we use proprietary fixes. Some of our clients want to add it to their portals. And so, we’re adding a variation of where providers need to go to get that information. And in my experience, and you guys may have a different one, in order to get someone to move above a floor, if we allowed X12 or other standards to be an option instead of going to APIs on these other fixes, it’s going to have to take a really good business case value proposition to get someone to move.

And so, I think the nervousness of having all these different types of connections actually would be minimized with a floor, with the ability to go up with X12 so we can utilize X12 instead of going outside to the proprietary API and the portals, would actually make it a better experience for the end-user, as well as the opportunity to test. Because what we totally don’t have again, is that CQI. If you’re able to use those more common versions, when we get to 7030, and we just have yearly updates, now we can sell the business case.

And if I would go to X12 and have something for a specific specialty that’s really going to help them, why in the world can’t I bring that to them that following year instead of waiting for the five years it’s going to take?

We can say a year; it’s going to take five years. So, then we can up the floor every five years and guess what? We’ve already tested it. We’ve already brought back – hopefully because we are having this consortium, we’re communicating more right – we’re bringing it back because we know it can be put into that standard and upgraded. Or again, if it’s not something appropriate, we can use other types of new technology as well. So, there’s not a limit, but we’ll know if that X12 future standard is really viable for the need before it becomes mandated. Just my two cents.

SPECTER: Sure, I’ll jump in with this innovation discussion. So again, we support innovation and doing what we need to do to improve upon the standards and what we’re doing now. But we also think that we need a good pilot program in place and that goes back to, is that something that this new entity is going to have within their jurisdiction. But we really need to be able to evaluate projects that are happening. So, when we have these innovative uses, that we can really learn from those experiences. And so, with that, we also believe that there should be CMS oversight of these pilots or these innovative implementations that are happening, so that we can really track what is happening. Is it better? What the experiences are and can then use that to move forward with what would then become a standard.

LESTINA: The only thing I would caution as I listen to these comments – I know we’re jumping ahead a little bit – is just to be careful how do you determine what’s above the floor versus what’s not in compliance.

Because to me, this opens Pandora’s box, and unless it’s clearly defined, anybody could just about say anything, and it becomes one testing above the floor, when in fact what it is, is we’re really just out of compliance with the floor standard. So, somehow that has to be carefully considered as a part of this.

SPECTER: I just want to throw in, that’s our thought with registering sort of the projects with CMS, so that you would know then that this is a project and not just a noncompliant situation.

KOCHER: I want to say ditto to Suzanne. I think what we’re defining flooring baseline as is very critical. When I hear those words, I hear we start with something and then we make changes to that and layer it on top, which is different from, we have something that we all have to do, but we want to try this new different technology over here. If we’re layering with slight changes to what we call our flooring baseline, that makes me think back to the days of 4010 and all the complaints and concern about the variability that we saw across the industry. And I think the last thing any of us want to do is go back to that point where providers felt like they had to have 15 different implementations for 15 different payers.

I’m hoping that’s not what these are intended to mean, but I think the words, the way they were written in some cases, that’s what came out. At least to some of us. So, I think the semantics as we move forward of what we’re calling it and how we’re defining it are absolutely critical.

GNAGY: So, I’ve heard a lot of mention of projects and test scenarios. All of these, in my opinion, are really above where we need to be gathering the information. These are out of the standard business, secondary projects. Whereas if we can somehow determine or figure out a way to implement a method in which we can actually get in and leverage the people doing their jobs, actively working to resolve problems instead of joining a group to test the theory of a problem, or to get this, you’re going to have a lot better data. You’re going to have a lot more data to then make these decisions for predictability.

Because what do you need to predict? You need information on the process. You need information on what the people are doing and how they’re doing it. And if you offer that at the very low level where people like me and people that I employ, who are actively working with third parties, with payers, to get these one offs, to get these workarounds, you’re going to see that. And you’re going to see that you’re going to have access to that data prior to making these secondary elements and then you leverage it for free and all the above.

So, there’s a lot that I’m hearing about opportunities that need to open up and that can be done within the standards. You have to give the opportunity for what you’re working with to move with technology to be organic. And you don’t do that by saying, here’s your floor and you put a period at the end and then you say, you can do anything else you want outside of that. That’s a giant can of worms that we don’t ever want to get into. No.

COUSSOULE: I think there’s a real challenge in how innovation happens, and it’s frankly not predictable. So, if we sit back and try to put a huge structure around how innovation will happen, it won’t. So, I think, what I’ll call the free exchange of ideas and creativity, needs to be allowed to flourish. And eventually you figure out what works and what doesn’t. And the best ideas are eventually we’ll win. And there needs to be some kind of a framework around that.

I’m generally at least overhead model guy, but I want to make sure as we think about how to – if we decide and we and we think a floor is the right idea but we want a lot of creativity is, how do we allow the most creativity without allowing things to go off the rails and then realize we’ve got 40 answers to the same problem and everybody has to implement all of them. So, I think we do need to be a little careful not to stifle innovation as part of that process.

LANDEN: I’m going to interrupt here. I’ve got a view on the clock and this discussion seems to be taking us a little farther afield from the recommendation that we’re addressing here. I notice that our tough cop sitting next to me has not wielded his baton yet.

(Laughter)

Before he does that, let me just ask that if you’ve got some – on this topic we’ve got one or two tents were up, but let’s keep them significant. We’ll move on to the next conversation, which is very similar to the one we’ve done. You will have an opportunity to get back into the floor and what that means discussion, farther down the agenda probably tomorrow.

So, any other remaining comments on this particular recommendation? Okay. Thank you for that discussion. It was extremely enlightening. It points out that, yes, indeed, healthcare is complicated.

LANDEN: Moving onto the next slide then, Recommendation 9. My view of the world is that this is kind of a logical sequel to the previous slide which talks about the one-year timeframe. But it’s a little broader in the sense that, regardless of what the timeframe is, the agencies doing the regulatory development need to be appropriately staffed for their obligations. So, the wording is, “HHS should ensure that the operating division responsible for education enforcement and regulatory processes is appropriately resourced.” I think that’s kind of motherhood and apple pie. But again, that’s my thought. This is a hearing, so we need to hear what your thinking is on this, if you do have no thoughts to this recommendation.

WEIKER: NCPDP agrees with this recommendation.

(Laughter)

GASH: I agree too. However, I just want to add a little color here. The last time I sat in on an education session around a new standard that was coming out, the educator, all they did was just reread what was in the publication and couldn’t really teach or explain or discuss the implementation. So, I agree with it, but when I hear appropriately resourced that means that they know what the rule is. They understand what it means and how to implement and understand the technology behind it, because what is offered today in the education I’ve experienced is not valuable.

TENNANT: One thing I would recommend here is this as a standalone is one thing, but you may want to reference some of the activities of the current administration. So, for example, CMS administrator has come out strongly looking at the issue of reducing physician burden, but also calling for the elimination of faxes by 2020. And I think looking at this in total, you can make a strong argument that improving the standards development process, making healthcare administration more efficient, is going to achieve some of the administration’s goals and because it’s integral to that goal, CMS needs to be sufficiently resourced to make that happen. I think that’s a broader message to send to the administration.

COMBS-DYER: This is Melanie, I second that.

COUSSOULE: One of the challenges with a recommendation like this is, if you agree with Recommendation 8 that there should be some kind of timeframe or cadence that’s regular, this really is irrelevant if that’s agreed. First I would ask if you agree with that, but part of the reason this came up is it’s come up over the last 18 months as we’ve talked about some of the challenges of this happening, it just doesn’t seem to be enough bodies engaged in the process to move it along as fast. So, resources have come up as a specific issue almost different but related to whether the pace is appropriate or not. So, that’s why these two are separate. Otherwise, if you said, well, if we just had the cadence, then why do you need to even talk about resources? Because if you have to execute the cadence, you execute the cadence. Just something to think about, whether they really do stand alone as separate items or whether they all roll together.

BELL: I just can’t believe no one said that they should inappropriately staff and resource, but I think I heard your point really being, what HHS has to accomplish and should we be focusing more on, this is what you need to deliver and this is the way that you delivered it rather than just calling them out saying, well, you need to appropriately – to what extent? What is appropriate? I know in some of these recommendations it’s specifically telling them what the goals are, but I’m not sure it’s all- inclusive as far as the education and what is appropriate education.

SAWYER: One thing we might have to look at for predictability – a lot of people I’ve talked to said, if we do this more frequent, even smaller, more frequent updates, it might actually require some increases in certain resources to be able to do that. If we’re doing that, maybe it’s not appropriately resourced. Maybe the recommendation is that CMS, HHS is actually going to have to increase their resources to be able to handle this. It’s appropriately resourcing it, but it’s getting it to the point that actually makes this predictability and rapid turnaround happen. It might be a difference in words that we actually need the recommendation is that they increase their resources be able to allow this to happen. Thanks.

LANDEN: Okay, thank you. Moving on then, now we’re getting into some calls for actions as opposed to recommendations to HHS. Public and private stakeholders should collaborate to design a single coordinated governance process. Governance should include detailed and enforceable policies regarding business practices including policies for identifying and implementing best practices in such an organization.

This picks up on our theme of the DSMO and I know that our conversations have been across the board here.

There have been some positions that DSMO should be eliminated, not replaced. There has been conversation that DSMO can be restructured. This particular phraseology is going down the path of NCVHS kind of throwing it out the industry and asking, okay, if we do go through with a – again we’re calling it governance, but we’re meaning stewardship, collaboration, coordination – if we go with that concept, we’re kind of asking you what it should look like.

We’ve gotten a lot of ideas earlier. I don’t know if you have been able to think about this over lunch and since we first talked about some of the concepts for, is there merit to renewing the DSMO? And again, remember there is an MOU. That MOU already includes terms that it can be amended, new organizations added to it, so that’s one avenue. What have you been able to think about since we last talked about the DSMO that you might want to add to your testimony here?

WEIKER: When NCPDP read this, we didn’t think it was about the DSMO. When we read it, we saw public and private sector stakeholders. So, I have a bunch of payers, I have a bunch of providers, I have a bunch of vendors, clearing houses, whatever it may be, and they need to get together and come up with some policies regarding their business practices. That’s how we read it and thought,

whoa, people would have some issues with this. Because if we go back and look – and there was testimony at one point in time and it talked about coming up with national edits that we would agree to on a national level, and Colorado had something in place where they had started implementing this where all the payers agreed that this would be these edits that everybody would implement. So, when we read that, mainly me, doing interpretation, that’s what I thought you were talking about was that type of initiative and not the DSMO again.

GOSS: Thank you Margaret. Our boss, our primary audience is the Secretary, but some of the challenges are not just the black hole of the regulatory process, it’s the industry. And this was really our attempt to ensure that the industry’s voice was brought to the table in trying to figure out what were the details of the DSMO 2.0. Words matter and sometimes it’s hard to get all your meaning across in those words.

DARST: I am going to ditto Margaret. When we looked at this from a WEDI perspective, we weren’t sure what was really being conveyed with the recommendation and really are seeking for clarification. So, we couldn’t really respond either.

LANDEN: Thank you for that input. That comes as a surprise to me in that the language – we thought one thing within our ivory tower and it read differently out in the real world or the unreal world, whichever. But yes, there’s food for thought and there’s nothing that we do that essentially applies to one and only one segment.

Whether we were talking about the DSMO specifically or governance – and again that’s a very strange and strained word – it’s good to hear that’s how you read that, and we apologize if we were not clear on that. There is no thought in NCVHS, and correct me if I’m wrong on this, of meaning or intending in this to impose any sort of governance on the SDOs ala what Margaret had brought up as an example.

Thank you.

All right, the next Call to Action, Slide 29, this is C as in Charlie. This one gets interesting. HHS and the SDO should identify and fund a best of class, third party compliance certification/validation tool recognized and approved by each standards development organization to assist in both defining and assessing compliance.

HHS should develop and test criteria for certification and build a program to enable multiple third parties to qualify to conduct the validation testing by demonstrating their business value. To implement this recommendation HHS should look at successful precedence such as how the ONC certification criteria was developed for promoting interoperability, formerly known as Meaningful Use, and with the e-prescribing requirements which were a joint effort between HHS, NIST, National Institute of Standards and Technology, and the SDOs.

This call to action was intended to ensure that covered entities had voluntary access to free or affordable compliance checking tools that could be used at a point in time. One of the challenges that exists through any type of significant changes in regards to technology or rule changes to ensure that all parties that need to participate can do so effectively.

In order for that to happen, you need to have a good understanding of what the changes are, but what each of the players in the ecosystem needs to do to make that change. Then you need to give people an ability to test and validate what that change would be in their own environment.

One of the challenges we have faced historically is that there is not an easy way to understand what an effective implementation would look like. Absent that, trading partners work on these initiatives separately and do not benefit from best practices. This recommendation is envisioned A, as a consistent way for industry to validate the changes that they’ve proposed or are making, using a tool or tool that the standard’s organizations agree accurately assess compliance with the requirements of the standard. Discussion.

WEIKER: NCPDP agrees with this. The SDO that’s referenced is NCPDP and we had a very successful precedent in regard to doing this. Version 10.6 was the version that was named of our Script Standard, which is our E-prescribing Standard, not named under HIPAA. And it was named certain functionality, certain transactions of that was mandated for Meaningful Use. So, a tool was built between NIST, ONC provided guidance in what was the criteria, and then NCPDP formed a task group where we came up with the use cases for validating these messages, wrote them out, helped develop the data for that.

And then what we have done since then, because 10.6 is 10.6, the new version of script, which has been named to be mandated in January 1st of 2020, we already have up and available, a testing tool, free of charge, right now, to entities to test Version 2017071. So, it’s available. We have a context free where you can just submit your transaction and it basically tests for syntax errors, those type of things. And then we have a context base, which is basically a scenario that you walk through and you send something, we send something back. We send a message back based upon that. Then you send another message so it’s a more interactive type of thing. That is available today.

And for the certification piece, NCPDP does not certify 10.6. Through ONC and ANSI they have named, I believe there are five entities, that can certify on 10.6, but those five entities use this tool to do their certification. At this point NCPDP does not do the certification piece of it. So, we’re in support of taking that model and moving it to the next Telecom, X-12, those types of things, moving it forward.

TODD: CORAE is also supportive of certification programs. CORAE operates a certification that covers over 65 percent of covered lives in the U.S. or in a plan that has some sort of level of CORAE certification. We also work with a third party that runs that certification program. The comments that we have on this area is that HHS not duplicate existing efforts but work in collaboration with those that exist to learn from the successes that have occurred and expand that throughout the industry.

TENNANT: There is sort of ups and downs to this recommendation and to site the ONC, certify the HR technology as an example, is probably not correct. That was designed specifically in 2011 to support the Meaningful Use EHR reporting program. There was sort of a definite carrot and stick approach with that program and it was not funded by HHS. So, they anointed certain authorized testing and certification bodies, but those entities, private-sector entities then tested software and charged the vendor for that service. We think that’s probably, frankly, a better approach rather than HHS develops this and maintain it, we would like to see them more anoint a private-sector effort.

And I would say, from the provider perspective, I don’t think it’s good enough to simply certify that, for example, practice management system software, has the capability of supporting the range of transaction standards. For software to be effective in a physician practice it has to have multiple functionalities. And so, we would encourage any certification process to be broader in scope and to be something that physician practices could get behind. I know Tammy, I’m sure, is going to talk about HATA, but we believe the private sector is the way to go here.

BANKS: I’m going to let Brad talk about CHAD from the HATA perspective, but just from Optum360 perspective, we along with other vendors already have invested the time and effort into building these type of validation tools that are widely used throughout the industry. And they just wanted to convey to me that these capabilities, while they’re built on the core of HIPAA, they actually extend much further into ICD-10, into 70 plus other industry code sets as well. They have custom payer defined rules and edits to increase first pass claim payment rates and other types of capabilities, and they also have the ability to certify transactions for HIPAA compliance.

But one of the big things that they indicated that when 5010 came to be, the standard development bodies in HHS brought these vendors together to ensure that those HIPAA compliant capabilities were all consistently applied within these validations engines and to strongly encourage that that continue. And also, that they would recommend working toward, as Rob said, providing an approved vendor list for these capabilities, as well as increase the education, access, and outreach, regarding the need for these types of tools in order to ensure you can proactively test and prepare for future changes in the standard transactions as well.

But I do want to just add one word of caution when we’re talking about HIPAA validation engines, is that today many health plans relax these rules, so if there is

going to be a required mandate to meet these that we’ve got to strongly consider that. Why did they relax them? Because they want to make sure that they get these claims in through the front door. And so, a lot of different payers are not going to do all of these roadblocks and just reject claims depending on what their analysis is of their population, they’re going to accept them. And slowly the trend is to educate ahead of time before they start putting in some these more WEDI/SNP coding types of errors. So, you just want to keep that on the back burner, if we’re going to mandate something like this, what the unintended consequence could be.

JAFFE: I think there are a number of challenges when you come to a broad portfolio of standards such as those developed by HL7. We have conformance testing, we have certification testing, in FHIR there’s a resource to support this, but there’s a big difference between whether you’re talking about syntactic interoperability and semantic interoperability. Without getting into the nuance of medical informatics, the critical portion here is we can exchange the zeros and ones seamlessly and demonstrate that that sender and recipient agree on them, but it’s difficult to agree on the meaning of the words. That will be a challenge moving forward, particularly as we enter an era of value-based care. I caution people when they evaluate this proposal to look and see if they’re really getting what they hoped to be paying for.

MIKKILI: We do support the third-party validation tool, but at this point we do not believe we need a certification program to validate the compliance for the standards. It will incur cost and that eventually will be passed on to the payers and the providers.

ALSCHULER: We certainly support a plethora of validation tools. I’d like to suggest, perhaps, separating the concept of encouraging the development of validation tools which can be used continually through a development test and implementation process from tools for certification. One thing we have found in looking at the clinical data that’s exchanged under Meaningful Use out of certified systems, is it is not compliant. It is highly not compliant. And there is great statistics from several of the exchanges indicating this. Somehow there has to be a way to make compliance apply in production and that’s not a lab situation the way the testing has been done. It has to be able to deal with PHI and deal with, on some kind of basis, ensure that in production, systems are just as compliant as they are in the lab.

COUSSOULE: Just one point of comment to really piggyback a little bit on what Tammy was talking about a little earlier is, I do think that if we are going to recommend something like this, there is a possibility that this gets used as a way to actually create more friction rather than less. I’m speaking out from a payer perspective, if we got as aggressive as we could in regards to the edits, we could stop a whole lot of claims from coming in. That’s just not productive for anybody.

Now, we don’t do that, so we do relax. We try to make the world flow better. And so, I think there’s an interesting way to think about this is, how do you make the world flow better but not create artificial barriers to restrictions. So, I do think that is something to think about in this process.

CAMPBELL: I’ll ditto what Menill said as well. Our experience with certification is that, while it may have brought more systems into compliance and more alignment to round standards it came at a huge, huge cost to the entire industry. Not just the financial cost to the taxpayers, but also the opportunity cost in implementing it.

And I would say that given all of the other enforcement pieces that we have in place here whether it’s oversight, auditing, or the wall of shame, or everything else I would agree that separating that validation from certification makes sense. And then maybe the certification recommendation is okay after we’ve done those other things, reevaluate of certification is still necessary to move the industry to where we want it to be.

GOSS: Gary, then Brad.

BEATTY: Gary Beatty X12. What we suggest is rather than have HHS and the SDOs do this is that we recommend revisiting that the SDOs and the ORAEs would provide the endorsing or certification validation, which I also believe are two separate concepts, in tools related to the use of those standards and operating rules, as they deem appropriate. X12 supports the concept of HHS participation and joint funding of such ventures. Because gaining consistency across all the tools would be a very valuable thing. And the source of the information that they’re validating against is the standards and operating rules and the people that knows those best are those organizations.

GNAGY: I’ll echo a few of the comments out here. The cost of certification and again the separation of certification and validation against the standard is key in my opinion. It can be significant depending on the size of the vendor and can range in terms of not just the cost to the person or the company getting the certification, but the same certification for a company that’s got 40 employees versus the same certification than a company that has 5,000 or 10,000. When we’re doing a CHAD certification where it’s much lower, at lower end in terms of the use of the practice management system, what you can get out of it, what sort of transactions are being processed, and not necessarily a validation of the standard itself, but more of the software and what it can do.

LANDEN: Just a response to a couple of the points brought up. Yes, we are aware that the ONC as an example of the certification is not exactly the same as certifying to the HIPAA transactions and operating rules but is a similar concept and that’s why we had that out there. The ONC was more looking at the functionality of the HRs and it was measuring the EHR at the developer, not at the installation site. So very, very different matter, but similar concept.

The other point that I wanted to raise is, I didn’t hear anybody link the certification or validation tools. And yes, I appreciate the comments about validation does not equal certification but linking these tools for the concept we talked about earlier this morning with the CMS enforcement and what’s the role of a third-party validation or certification tool relative to the job that these recommendations call for CMS doing. Does it help?

Does it hinder? Will it allow the trading partners to at least identify whether they have an issue before a complaint needs to be filed? Any thoughts to that? It may just be the end of the day. Margaret?

WEIKER: I do think it would be a tool that you could use when I’m a provider and I say payer, you’re not in compliance, because I can’t send this value. And the payer says, no, you’re not in compliance. You could submit this transaction de-identified, obviously, to all that was agreed upon only if there is one tool or multiples to see if it does meet the criteria of, is it valid or is it not valid.

So, it could be a mechanism to avoid some of that or at least verifying to where somebody could say, oh, they are out of compliance according to this tool. I’m going to go report them. And they could say, I used this tool to verify that they are out of compliance, kind of thing. So, it could be a very useful tool for vendors to verify syntax and those type of things are correct. That’s out of the way of, is this compliant or not? It could be a useful tool.

ROOSA: A danger in that that I see is that if you’re going to stay compliant-driven in terms of enforcement and somebody is complaining against a payer for being out of compliance in a particular portion of like an 837 SPEC, and you use the compliance tool and suddenly there’s like 37 things that it pops up, the payer may be not happy about that situation and we would rather just fix the one thing that was being complained about rather than the entire swath of things. So, it could be an issue.

LANDEN: Okay, seeing no more comments I think we wrap this section up to conclusion and I think –

GOSS: Can we go to the next slide? I think we may have a measurement and I think we may be punting back to Linda to handle those. From a time-measurement perspective, we are aware that we have public comments that have been submitted so after we wrap up the measurement section we will just confirm tomorrow’s game plan and move to those five public comments that were submitted online.

KLOSS: The Outcome Goal 2: Measurement 2, calls for HHS and stakeholders participating in the new governance process establishing metrics for monitoring and performance assessment of the new entity and oversight enforcement of SDO and operating rule authoring entity deliverables and performance. I think, again, as we’re conceiving of this governance as a multi-stakeholder-entity we’re suggesting that metrics be a real foundational principal for the work of that group going forward. What were comments or reflections of your organizations on this measurement? Realizing it goes back to the fundamental discussion about the new entity itself –

PARTICIPANT: We need to evolve a lot more.

Margaret.

WEIKER: Linda, I think you hit the nail on the head. It goes back to what we said before around this other entity. And NCPDP doesn’t believe that there should be this entity so therefore we don’t think this measurement should exist.

BEATTY: One thing I would challenge you to, regardless of whether this entity existed or not, do we believe that the other participants have sufficient metrics that are visible, that allow the process to happen? I would be a little creative in the thinking about not knowing what the outcome of the other recommendation might be. Are there visible metrics that we should be paying attention to in this process?

PARTICIPANT: I think regardless of whether the entity exists or not, metrics and reporting against those metrics are important. I think the SDOs and ORAEs could work cooperatively to produce those metrics and then report against those metrics. I think it doesn’t matter whether the entity exists or not, metrics are  important and reporting against that is also as important.

KLOSS: Outcome Goal 2: Measurement 3. NCVHS should continue to conduct its stakeholder hearings to assess progress of the predictability roadmap.

WEIKER: We agree. (Laughter)

GOSS: Wow, this has been an amazing day. I suspect all of us are pretty brain dead at this point because it’s been such great conversation. Thank you, Nick. One of the things that we want to do is to confirm our plan for tomorrow as we slide into our public comment period.

Tomorrow, I believe we’re starting at 8:30 in the morning, which is a little bit earlier than we started today. Debra Strickland will be guiding us through the Outcome Goal 3 sections and we will spend the majority of the day on that before looking at wrapping up some conversation if we have time around prioritizing recommendations and interdependencies, but also ensuring that we have a public comment period for tomorrow as well. Any questions about the plan for tomorrow?

Please note that we are inviting all of our participants and guests to join us for a little bit of a networking opportunity at the closure of this meeting today. We’ll provide those details on the screen when we wrap up, but I believe I need to turn it over to Rebecca to walk us through the submitted public comments.

Agenda Item: Public Comments

HINES: Thanks, Alix. So first we’ll start in the room. Is there anybody in the room who has a public comment? I’ve got five comments from the WebEx, and I’ll start all the way from the morning. The first comment came from Sam Rubenstein while we were in the morning section. “One, I think the compliance needs to be looked at not from just the ability to process a specific transaction set, but also compliance should include some indication as to the use of a transaction of combinations of transactions to accomplish an end-business objective without issue.

Two, I would like to ditto the comment related to accomplishing the end-goal or automation of the process.

Should it be considered to have entities report on a periodic basis as to instances where there was not support for a given transaction and/or the transaction information returned to the sender required additional intervention, say looking up more detail on a payer website?”

Comment number two, Stanley Nachimson, also from this morning. He wrote some comments on the morning discussion. “While there may be a cost for an entity to become compliant, there is a bigger cost for all of their trading partners to develop workarounds to get business done. That is why we are pushing standardization. Second, regarding WEDI and others developing best practices and solutions, this has been happening since the beginning of HIPAA. The problem is that there is no requirement to use those best practices or solutions, so the suggestions are often ignored. It is only CMS regulations that folks pay attention to.”

Third comment from Sam Rubenstein again, “Again, let’s not forget that the end products that say the provider is, for example, the performance of a referral authorization transaction and to what optimal business process is to improve financial performance and improve consumer satisfaction and improve outcomes. Two, the transactions behind the scenes and the technical discussion behind them are usually vendor or IT related. With regard to the definition of a provider, there is an endless count of different types: physician providers, other clinical providers, like therapists, nutritionists, nursing homes, hospitals, institutional providers, DME, pharmacy, etcetera. I think we need to look at who, of those various entities, is the appropriate person and it would most probably be different based on the usage.

Fourth comment, also from Sam Rubenstein, “I support that WEDI could be the supporting body for this.” I believe that was during the DSMO discussion. That came in at 2:00.

And last from Stanley Nachimson, “It would be nice if we didn’t need the government to mandate the standards, but the industry has asked for it. Here is my current thinking. One, if you want standards then development, review, implementation, and enforcement is a cost of doing business. Industry must accept that and stop looking for someone else to pay. This is true even for small providers. SDO participation is part of that cost.

Two, you can’t have both mandated standards and innovation at the same time. If you want innovation you have to provide a lab for doing that and suspend standards in that lab. Three, stop depending on the federal government to fund so much. Industry has to move forward and fund this work. Four, if you really want standards to be used by everyone, step up the enforcement. If you really don’t care and are happy with workarounds, then ease up.

Last, somehow we have to hold vendors responsible for their products implementing the standards.”

There you go. Five comments through the Webex.

None in the NCVHS mailbox. None in the audience. So, I think with that public comment, it is finished for this afternoon.

Agenda Item: Closing Remarks & Adjourn

 COUSSOULE: I want to just express my thanks to everybody in the room for coming. It’s been a long day, but I think a very productive day with lots of really good input. I think we’ve challenged each other in a lot of ways. It’s been done very professionally and very thoughtfully. I speak on behalf of the rest of the committee, we greatly appreciate that effort.

For those of you who do, we will start at 8:30 in the morning, so please be here – change that, we’re going to start at 8:25, so then we’ll be ready at 8:30 in the morning, but we look forward to as many of you hopefully being able to participate with us in the morning as well.

We will be meeting for a little bit of a social get together pretty much now for whoever can do that down at the marquee so, if any of you would like to join, there will be several members of the committee there as well, but we would love to be able to just talk to you in a little more informal setting if you all can do that. With that said, I think we are now officially adjourned for the day. The marquee is just down by the lobby. Thank you all.

(Whereupon the meeting was adjourned at 5:00)